THERMACARE LOWER BACK & HIP
Report
- Report Number
- 1066015-2018-00049
- Event Type
- Injury
- Date Received
- April 9, 2018
- Date of Event
- April 3, 2018
- Report Date
- April 5, 2018
- Manufacturer
- PFIZER CONSUMER HEALTH CARE
- Product Code
- IMD
- PMA / PMN Number
- K953442
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
THIS INVESTIGATION WAS CONDUCTED FOR AN UNKNOWN LOT NUMBER LOWER BACK/HIP (LBH) 8-HOUR PRODUCT. THE ROOT CAUSE CATEGORY IS NON-ASSIGNABLE (COMPLAINT NOT CONFIRMED AS A QUALITY DEFECT). THERE WAS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED, NO BATCH NUMBER OR RETURN SAMPLE WAS AVAILABLE FOR EVALUATION. WITHOUT A BATCH REFERENCE NUMBER AND/OR RETURN SAMPLE A MANUFACTURING AND TECHNICAL EVALUATION CANNOT BE COMPLETED FOR THE WRAP INVOLVED IN THIS CASE. THERE IS NOT A PRODUCT QUALITY RELATED TREND IDENTIFIED FOR THE SUBCLASS ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. THE MANUFACTURING OPERATIONS EMPLOY QUALITY CONTROL PROCEDURES WHICH INCLUDE IN PROCESS TESTING, THERMAL TESTING AND VISUAL INSPECTION, TO ENSURE THE QUALITY OF THE PRODUCT BEING PACKAGED.
EVENT VERBATIM [PREFERRED TERM] RED BURN ON LOWER BACK/PAIN/UNCOMFORTABLE/BLISTERS ON HER LOWER BACK/IT STARTED HURTING [BURNS SECOND DEGREE] , SHE WAS INJURED BY OUR PRODUCT [INJURY ASSOCIATED WITH DEVICE] , NOT SLEEPING SINCE TUESDAY/CANNOT SLEEP WITH THE BURNS ACROSS HER BACK [INSOMNIA] , SHE HAD TRIED LYING ON HER SIDE BUT IT WAS SO PAINFUL WHEN SHE ROLLED OVER IT WOKE HER UP [TERMINAL INSOMNIA] , SHE CANNOT LAY DOWN, SHE CANNOT SIT FOR VERY LONG AND LEAN UP AGAINST IT [MOVEMENT DISORDER]. CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER (MEDICAL ASSISTANT) REPORTED FOR HERSELF. A 55-YEAR-OLD FEMALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP), FROM AN UNSPECIFIED DATE AT AN UNSPECIFIED FREQUENCY FOR LOW BACK PAIN. MEDICAL HISTORY INCLUDED BACK SURGERY 5-6 YEARS AGO. THERE WERE NO CONCOMITANT MEDICATIONS. THE PATIENT REPORTED ABOUT THERMACARE HEAT WRAPS FOR LOWER BACK. SHE NO LONGER HAD THE PACKAGING TO READ THE EXACT NAME OF THE PRODUCT, BUT DESCRIBED THAT THEY WERE THE KIND THAT WRAP AROUND YOUR LOWER BACK AND SECURE WITH VELCRO IN THE FRONT, WITH HEAT CELLS ON THE BACK. SHE HAD USED THE SMALLER PRODUCTS BEFORE THAT WERE ENVELOPE SIZED AND YOU JUST STICK TO YOUR BACK. SHE STATED THAT SHE USED THEM EXACTLY AS DESCRIBED IN THE PACKAGE INSERT. THE CELLS WERE UNCOMFORTABLE UNLESS YOU HAD ON CLOTHING UNDERNEATH. SHE HAD A T-SHIRT ON AND PUT THIS ON OVER IT AT 6PM TUESDAY NIGHT ((B)(6) 2018). IT STARTED WARMING UP AND FELT NORMAL. AT 11PM- IT STARTED HURTING. THERE WERE NOW RED BURNS ON HER LOWER BACK ON (B)(6) 2018. THE BURN WAS STILL PAINFUL AND SHE HADN'T SLEPT SINCE TUESDAY ON (B)(6) 2018. IT WAS ON HER LOWER BACK AND HURT ANYTIME CLOTHING HIT IT OR WHEN SHE WAS CHANGING POSITIONS. SHE HAD TRIED LYING ON HER SIDE BUT IT WAS SO PAINFUL WHEN SHE ROLLED OVER IT WOKE HER UP. SHE DID NOT SEEK ANY CARE FOR THEM BECAUSE SHE SAID SHE KNEW SHE WOULD BE TOLD TO JUST PUT NEOSPORIN ON IT AND TAKE SOME IBUPROFEN FOR PAIN. SHE TREATED THE PAIN WITH IBUPROFEN 600MG. IT HAD NOT TOUCHED THE PAIN. THE PATIENT FURTHER STATED SHE WAS INJURED BY OUR PRODUCT AND IT WOULD PROBABLY LEAVE SCARS. THE PATIENT STATED SHE HAD BURNS AND BLISTERS ON HER LOWER BACK FROM THIS PRODUCT. SHE COULD NOT PUT CLOTHES ON OVER IT WITHOUT IT BEING PAINFUL, SHE COULD NOT LAY DOWN, SHE COULD NOT SIT FOR VERY LONG AND LEAN UP AGAINST IT. SHE COULD NOT SLEEP WITH THE BURNS ACROSS HER BACK BECAUSE THEY WERE SO PAINFUL. THE PATIENT WOULD ALSO LIKE SOMEONE TO ACKNOWLEDGE HER BURNS AND APOLOGIZE FOR THIS EVENT. THE PATIENT REQUESTED A FOLLOW UP PHONE CALL MULTIPLE TIMES BUT WAS INFORMED SHE WOULD RECEIVE FOLLOW UP MAIL. THE PATIENT WAS VERY UPSET AND IRATE. SHE STATED SHE WOULD LIKE SOMEONE TO CONTACT HER DIRECTLY TO ACKNOWLEDGE THIS EVENT AND INJURIES. THE PATIENT MENTIONED TAKING ACTION AND THE WORD ATTORNEY DURING THE CALL AND THEREFORE WAS OFFERED TO BE GIVEN PFIZER LEGAL DEPARTMENT ADDRESS, HOWEVER THE PATIENT DECLINED. THE PATIENT STATED IF SHE FELT LIKE SHE CONTINUED TO GET JERKED AROUND SHE WOULD CONTACT AN ATTORNEY. THE PATIENT FURTHER ADDED, THE OUTCOME OF THIS WAS GREATLY DEPENDENT ON IF SOMEONE PICKED UP THE DAMN PHONE AND CALLS HER BACK TO ACT LIKE THEY CARED. IF THEY DID NOT THEN SHE WOULD ASSUME SHE NEEDED TO BRING IN SOMEONE PROFESSIONAL TO HANDLE THIS. IF SHE DID NOT HEAR FROM SOMEONE SHE WOULD ASSUME NO ONE GIVES A DAMN AND WOULD BE MORE THAN HAPPY TO PURSUE THIS IN A ANOTHER AVENUE. SHE STATED RIGHT NOW HER NEXT AVENUE WAS DEPENDENT UPON IF SOMEONE FROM OUR COMPANY CALLS HER AND GAVE A DAMN ENOUGH TO ALLOW HER TO SEND THE PICTURES. RIGHT NOW SHE WAS JUST LOOKING FOR AN APOLOGY. SOMEONE TO LOOK AT THEM AND SOMEONE TO SAY I'M SORRY. IF SOMEONE DID NOT LOOK AT THIS COMPASSIONATELY THIS COULD GO IN A COMPLETELY LITIGIOUS WAY. SHE HAD THE WRAP ITSELF, BUT THREW ALL THE WRAPPING AWAY. DEVICE WAS AVAILABLE FOR EVALUATION. SHE DID NOT HAVE ANY OF THE PACKAGING FOR THE WRAP TO GIVE LOT NUMBER, EXPIRATION DATE, OR UPC. PACKAGING WAS SEALED AND INTACT. ADDITIONAL LOT NUMBERS: M19505, EXPIRATION DATE (B)(6) 2018 WERE PROVIDED. THIS WAS ANOTHER WRAP OF THE SAME KIND THAT SHE PURCHASED SEPARATELY. THERE WERE NO INVESTIGATIONS. THE ACTION TAKEN IN RESPONSE TO THE EVENTS FOR THERMACARE HEATWRAP WAS UNKNOWN. THERAPEUTIC MEASURES TAKEN AS A RESULT OF PAIN INCLUDED IBUPROFEN. THE OUTCOME OF THE EVENTS WAS UNKNOWN. ACCORDING TO THE PRODUCT QUALITY COMPLAINT GROUP: THIS INVESTIGATION WAS CONDUCTED FOR AN UNKNOWN LOT NUMBER LOWER BACK/HIP (LBH) 8-HOUR PRODUCT. THE ROOT CAUSE CATEGORY IS NON-ASSIGNABLE (COMPLAINT NOT CONFIRMED AS A QUALITY DEFECT). THERE WAS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED, NO BATCH NUMBER OR RETURN SAMPLE WAS AVAILABLE FOR EVALUATION. WITHOUT A BATCH REFERENCE NUMBER AND/OR RETURN SAMPLE A MANUFACTURING AND TECHNICAL EVALUATION CANNOT BE COMPLETED FOR THE WRAP INVOLVED IN THIS CASE. THERE IS NOT A PRODUCT QUALITY RELATED TREND IDENTIFIED FOR THE SUBCLASS ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. THE MANUFACTURING OPERATIONS EMPLOY QUALITY CONTROL PROCEDURES WHICH INCLUDE IN PROCESS TESTING, THERMAL TESTING AND VISUAL INSPECTION, TO ENSURE THE QUALITY OF THE PRODUCT BEING PACKAGED. SITE SAMPLE STATUS WAS NOT RECEIVED. FOLLOW UP (05APR2018): NEW INFORMATION RECEIVED FROM A CONTACTABLE CONSUMER INCLUDES NEW EVENTS (SHE WAS INJURED BY OUR PRODUCT AND SHE CANNOT LAY DOWN, SHE CANNOT SIT FOR VERY LONG AND LEAN UP AGAINST IT), "BLISTERS ON HER LOWER BACK" SUBSUMED UNDER EVENT BURN AND EVENT DETAILS. FOLLOW-UP (28MAR2020): NEW INFORMATION RECEIVED FROM THE PRODUCT QUALITY COMPLAINT GROUP INCLUDED INVESTIGATIONAL RESULTS. FOLLOW-UP ATTEMPTS ARE COMPLETED. NO FURTHER INFORMATION IS EXPECTED., COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENTS OF BURNS SECOND DEGREE AND INJURY ASSOCIATED WITH DEVICE AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENTS INSOMNIA, TERMINAL INSOMNIA, AND MOVEMENT DISORDER ARE CONSIDERED AS NON-SERIOUS AS THE EVENTS DESCRIBED IN THIS CASE DID NOT CAUSE ANY SERIOUS DETERIORATION IN STATE OF HEALTH OF THE USER NOR REQUIRED ANY MEDICAL INTERVENTION TO PREVENT A SERIOUS OUTCOME AT THIS TIME. ALL EVENTS ARE MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE. THERE WAS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED, NO BATCH NUMBER OR RETURN SAMPLE WAS AVAILABLE FOR EVALUATION. WITHOUT A BATCH REFERENCE NUMBER AND/OR RETURN SAMPLE A MANUFACTURING AND TECHNICAL EVALUATION CANNOT BE COMPLETED FOR THE WRAP INVOLVED IN THIS CASE. PRODUCT EFFECT VARIES WITH EACH INDIVIDUAL. NO REMEDIAL ACTION/CORRECTIVE ACTION/FIELD SAFETY CORRECTIVE ACTION IS SUGGESTED AT THIS TIME.
RED BURN ON LOWER BACK/PAIN/UNCOMFORTABLE [THERMAL BURN] , NOT SLEEPING SINCE TUESDAY [INSOMNIA] , SHE HAD TRIED LYING ON HER SIDE BUT IT WAS SO PAINFUL WHEN SHE ROLLED OVER IT WOKE HER UP [TERMINAL INSOMNIA] , . CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER (MEDICAL ASSISTANT) REPORTED FOR HERSELF. A (B)(6) CAUCASIAN FEMALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE LOWER BACK AND HIP), FROM AN UNSPECIFIED DATE AT AN UNSPECIFIED FREQUENCY FOR LOW BACK PAIN. MEDICAL HISTORY INCLUDED BACK SURGERY 5-6 YEARS AGO. THERE WERE NO CONCOMITANT MEDICATIONS. THE PATIENT REPORTED ABOUT THERMACARE HEAT WRAPS FOR LOWER BACK. SHE NO LONGER HAD THE PACKAGING TO READ THE EXACT NAME OF THE PRODUCT, BUT DESCRIBED THAT THEY WERE THE KIND THAT WRAP AROUND YOUR LOWER BACK AND SECURE WITH VELCRO IN THE FRONT, WITH HEAT CELLS ON THE BACK. SHE HAD USED THE SMALLER PRODUCTS BEFORE THAT WERE ENVELOPE SIZED AND YOU JUST STICK TO YOUR BACK. SHE STATED THAT SHE USED THEM EXACTLY AS DESCRIBED IN THE PACKAGE INSERT. THE CELLS WERE UNCOMFORTABLE UNLESS YOU HAD ON CLOTHING UNDERNEATH. SHE HAD A T-SHIRT ON AND PUT THIS ON OVER IT AT 6 PM TUESDAY NIGHT. IT STARTED WARMING UP AND FELT NORMAL. AT 11 PM- IT STARTED HURTING. THERE WERE NOW RED BURNS ON HER LOWER BACK ON (B)(6) 2018. THE BURN WAS STILL PAINFUL AND SHE HADN'T SLEPT SINCE TUESDAY ON (B)(6) 2018. IT WAS IN ON HER LOWER BACK AND HURT ANYTIME CLOTHING HIT IT OR WHEN SHE WAS CHANGING POSITIONS. SHE HAD TRIED LYING ON HER SIDE BUT IT WAS SO PAINFUL WHEN SHE ROLLED OVER IT WOKE HER UP. SHE DID NOT SEEK ANY CARE FOR THEM BECAUSE SHE SAID SHE KNEW SHE WOULD BE TOLD TO JUST PUT NEOSPORIN ON IT AND TAKE SOME IBUPROFEN FOR PAIN. SHE TREATED THE PAIN WITH IBUPROFEN 600 MG. IT HAD NOT TOUCHED THE PAIN. SHE HAD THE WRAP ITSELF, BUT THREW ALL THE WRAPPING AWAY. DEVICE WAS AVAILABLE FOR EVALUATION. SHE DID NOT HAVE ANY OF THE PACKAGING FOR THE WRAP TO GIVE LOT NUMBER, EXPIRATION DATE, OR UPC. PACKAGING WAS SEALED AND INTACT. ADDITIONAL LOT NUMBERS: M19505, EXPIRATION DATE JUN 2018 WERE PROVIDED. THIS WAS ANOTHER WRAP OF THE SAME KIND THAT SHE PURCHASED SEPARATELY. THE PATIENT BECAME UPSET. SHE STATED THAT SHE FELT LIKE SHE WAS NOT GOING TO RECEIVE ANY FOLLOW-UP REGARDING THIS BURN. SHE STATED THAT SHE WOULD NEVER BUY A PFIZER PRODUCT AGAIN. SHE MENTIONED THAT SHE DID NOT WANT TO INVOLVE AN ATTORNEY BUT THERE WOULD NEVER BE A MOMENT IN HER LIFE WHERE SHE BOUGHT ANOTHER PFIZER PRODUCT. SHE STATED THAT SHE FELT LIKE PFIZER DID NOT GIVE A DAMN. SHE WAS UPSET THAT WE CANNOT RECEIVE PICTURES VIA EMAIL TO ATTACH TO THIS REPORT. SHE STATED THAT SHE WANTED SOMEONE TO FOLLOW UP AND REQUEST THE PICTURES OF THE BURN TO HAVE IT DOCUMENTED. THERE WERE NO INVESTIGATIONS. THE ACTION TAKEN IN RESPONSE TO THE EVENTS FOR THERMACARE HEATWRAP WAS UNKNOWN. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF PAIN. THE OUTCOME OF THE EVENTS WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. COMPANY CLINICAL EVALUATION COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENT OF THERMAL BURN AS DESCRIBED IS CONSIDERED SERIOUS BODILY INJURY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENTS INSOMNIA AND TERMINAL INSOMNIA ARE CONSIDERED AS NON-SERIOUS AS THE EVENTS DESCRIBED IN THIS CASE DID NOT CAUSE ANY SERIOUS DETERIORATION IN STATE OF HEALTH OF THE USER NOR REQUIRED ANY MEDICAL INTERVENTION TO PREVENT A SERIOUS OUTCOME AT THIS TIME. ALL EVENTS ARE MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE., COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENT OF THERMAL BURN AS DESCRIBED IS CONSIDERED SERIOUS BODILY INJURY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENTS INSOMNIA AND TERMINAL INSOMNIA ARE CONSIDERED AS NON-SERIOUS AS THE EVENTS DESCRIBED IN THIS CASE DID NOT CAUSE ANY SERIOUS DETERIORATION IN STATE OF HEALTH OF THE USER NOR REQUIRED ANY MEDICAL INTERVENTION TO PREVENT A SERIOUS OUTCOME AT THIS TIME. ALL EVENTS ARE MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE.
EVENT VERBATIM [PREFERRED TERM] RED BURN ON LOWER BACK/PAIN/UNCOMFORTABLE/BLISTERS ON HER LOWER BACK [BURNS SECOND DEGREE] , SHE WAS INJURED BY OUR PRODUCT [INJURY ASSOCIATED WITH DEVICE] , NOT SLEEPING SINCE TUESDAY/CANNOT SLEEP WITH THE BURNS ACROSS HER BACK [INSOMNIA] , SHE HAD TRIED LYING ON HER SIDE BUT IT WAS SO PAINFUL WHEN SHE ROLLED OVER IT WOKE HER UP [TERMINAL INSOMNIA] , SHE CANNOT LAY DOWN, SHE CANNOT SIT FOR VERY LONG AND LEAN UP AGAINST IT [MOVEMENT DISORDER] , . CASE NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER (MEDICAL ASSISTANT) REPORTED FOR HERSELF. A (B)(6) CAUCASIAN FEMALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP), FROM AN UNSPECIFIED DATE AT AN UNSPECIFIED FREQUENCY FOR LOW BACK PAIN. MEDICAL HISTORY INCLUDED BACK SURGERY 5-6 YEARS AGO. THERE WERE NO CONCOMITANT MEDICATIONS. THE PATIENT REPORTED ABOUT THERMACARE HEAT WRAPS FOR LOWER BACK. SHE NO LONGER HAD THE PACKAGING TO READ THE EXACT NAME OF THE PRODUCT, BUT DESCRIBED THAT THEY WERE THE KIND THAT WRAP AROUND YOUR LOWER BACK AND SECURE WITH VELCRO IN THE FRONT, WITH HEAT CELLS ON THE BACK. SHE HAD USED THE SMALLER PRODUCTS BEFORE THAT WERE ENVELOPE SIZED AND YOU JUST STICK TO YOUR BACK. SHE STATED THAT SHE USED THEM EXACTLY AS DESCRIBED IN THE PACKAGE INSERT. THE CELLS WERE UNCOMFORTABLE UNLESS YOU HAD ON CLOTHING UNDERNEATH. SHE HAD A TSHIRT ON AND PUT THIS ON OVER IT AT 6PM TUESDAY NIGHT. IT STARTED WARMING UP AND FELT NORMAL. AT 11PM- IT STARTED HURTING. THERE WERE NOW RED BURNS ON HER LOWER BACK ON (B)(6) 2018. THE BURN WAS STILL PAINFUL AND SHE HADN'T SLEPT SINCE TUESDAY ON (B)(6) 2018. IT WAS ON HER LOWER BACK AND HURT ANYTIME CLOTHING HIT IT OR WHEN SHE WAS CHANGING POSITIONS. SHE HAD TRIED LYING ON HER SIDE BUT IT WAS SO PAINFUL WHEN SHE ROLLED OVER IT WOKE HER UP. SHE DID NOT SEEK ANY CARE FOR THEM BECAUSE SHE SAID SHE KNEW SHE WOULD BE TOLD TO JUST PUT NEOSPORIN ON IT AND TAKE SOME IBUPROFEN FOR PAIN. SHE TREATED THE PAIN WITH IBUPROFEN 600MG. IT HAD NOT TOUCHED THE PAIN. THE PATIENT FURTHER STATED SHE WAS INJURED BY OUR PRODUCT AND IT WOULD PROBABLY LEAVE SCARS. THE PATIENT STATED SHE HAD BURNS AND BLISTERS ON HER LOWER BACK FROM THIS PRODUCT. SHE COULD NOT PUT CLOTHES ON OVER IT WITHOUT IT BEING PAINFUL, SHE COULD NOT LAY DOWN, SHE COULD NOT SIT FOR VERY LONG AND LEAN UP AGAINST IT. SHE COULD NOT SLEEP WITH THE BURNS ACROSS HER BACK BECAUSE THEY WERE SO PAINFUL. THE PATIENT WOULD ALSO LIKE SOMEONE TO ACKNOWLEDGE HER BURNS AND APOLOGIZE FOR THIS EVENT. THE PATIENT REQUESTED A FOLLOW UP PHONE CALL MULTIPLE TIMES BUT WAS INFORMED SHE WOULD RECEIVE FOLLOW UP MAIL. THE PATIENT WAS VERY UPSET AND IRATE. SHE STATED SHE WOULD LIKE SOMEONE TO CONTACT HER DIRECTLY TO ACKNOWLEDGE THIS EVENT AND INJURIES. THE PATIENT MENTIONED TAKING ACTION AND THE WORD ATTORNEY DURING THE CALL AND THEREFORE WAS OFFERED TO BE GIVEN PFIZER LEGAL DEPARTMENT ADDRESS, HOWEVER THE PATIENT DECLINED. THE PATIENT STATED IF SHE FELT LIKE SHE CONTINUED TO GET JERKED AROUND SHE WOULD CONTACT AN ATTORNEY. THE PATIENT FURTHER ADDED, THE OUTCOME OF THIS WAS GREATLY DEPENDENT ON IF SOMEONE PICKED UP THE DAMN PHONE AND CALLS HER BACK TO ACT LIKE THEY CARED. IF THEY DID NOT THEN SHE WOULD ASSUME SHE NEEDED TO BRING IN SOMEONE PROFESSIONAL TO HANDLE THIS. IF SHE DID NOT HEAR FROM SOMEONE SHE WOULD ASSUME NO ONE GIVES A " AND WOULD BE MORE THAN HAPPY TO PURSUE THIS IN A ANOTHER AVENUE. SHE STATED RIGHT NOW HER NEXT AVENUE WAS DEPENDENT UPON IF SOMEONE FROM OUR COMPANY CALLS HER AND GAVE A "ENOUGH TO ALLOW HER TO SEND THE PICTURES. RIGHT NOW SHE WAS JUST LOOKING FOR AN APOLOGY. SOMEONE TO LOOK AT THEM AND SOMEONE TO SAY I'M SORRY. IF SOMEONE DID NOT LOOK AT THIS COMPASSIONATELY THIS COULD GO IN A COMPLETELY LITIGIOUS WAY. SHE HAD THE WRAP ITSELF, BUT THREW ALL THE WRAPPING AWAY. DEVICE WAS AVAILABLE FOR EVALUATION. SHE DID NOT HAVE ANY OF THE PACKAGING FOR THE WRAP TO GIVE LOT NUMBER, EXPIRATION DATE, OR UPC. PACKAGING WAS SEALED AND INTACT. ADDITIONAL LOT NUMBERS: M19505, EXPIRATION DATE JUN2018 WERE PROVIDED. THIS WAS ANOTHER WRAP OF THE SAME KIND THAT SHE PURCHASED SEPARATELY. THERE WERE NO INVESTIGATIONS. THE ACTION TAKEN IN RESPONSE TO THE EVENTS FOR THERMACARE HEATWRAP WAS UNKNOWN. THERAPEUTIC MEASURES TAKEN AS A RESULT OF PAIN INCLUDED IBUPROFEN. THE OUTCOME OF THE EVENTS WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. FOLLOW UP (05APR2018): NEW INFORMATION RECEIVED FROM A CONTACTABLE CONSUMER INCLUDES NEW EVENTS (SHE WAS INJURED BY OUR PRODUCT AND SHE CANNOT LAY DOWN, SHE CANNOT SIT FOR VERY LONG AND LEAN UP AGAINST IT), "BLISTERS ON HER LOWER BACK" SUBSUMED UNDER EVENT BURN AND EVENT DETAILS. COMPANY CLINICAL EVALUATION COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENTS OF BURNS SECOND DEGREE AND INJURY ASSOCIATED WITH DEVICE AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENTS INSOMNIA, TERMINAL INSOMNIA, AND MOVEMENT DISORDER ARE CONSIDERED AS NON-SERIOUS AS THE EVENTS DESCRIBED IN THIS CASE DID NOT CAUSE ANY SERIOUS DETERIORATION IN STATE OF HEALTH OF THE USER NOR REQUIRED ANY MEDICAL INTERVENTION TO PREVENT A SERIOUS OUTCOME AT THIS TIME. ALL EVENTS ARE MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE., COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENTS OF BURNS SECOND DEGREE AND INJURY ASSOCIATED WITH DEVICE AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENTS INSOMNIA, TERMINAL INSOMNIA, AND MOVEMENT DISORDER ARE CONSIDERED AS NON-SERIOUS AS THE EVENTS DESCRIBED IN THIS CASE DID NOT CAUSE ANY SERIOUS DETERIORATION IN STATE OF HEALTH OF THE USER NOR REQUIRED ANY MEDICAL INTERVENTION TO PREVENT A SERIOUS OUTCOME AT THIS TIME. ALL EVENTS ARE MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 250577 | THERMACARE LOWER BACK & HIP | DISPOSABLE PACK, HOT | IMD | PFIZER CONSUMER HEALTH CARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |