V.A.C. GRANUFOAM DRESSING
Report
- Report Number
- 3009897021-2020-00186
- Event Type
- Injury
- Date Received
- May 6, 2020
- Date of Event
- April 1, 2020
- Report Date
- April 6, 2021
- Manufacturer
- KINETIC CONCEPTS, INC.
- Product Code
- OMP
- PMA / PMN Number
- K160451
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
BASED ON THE ADDITIONAL INFORMATION OBTAINED REGARDING THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM. KCI'S ASSESSMENT REMAINS THE SAME; IT CANNOT BE DETERMINED THAT THE ALLEGED INFECTION IS RELATED TO THE V.A.C.® GRANUFOAM¿ DRESSING. THE DRESSING WAS NOT RETURNED TO KCI FOR EVALUATION AND AN IDENTIFIER WAS NOT AVAILABLE. THE ACTIV.A.C.¿ THERAPY UNIT PASSED QUALITY CONTROL CHECKS BEFORE AND AFTER PLACEMENT WITH THE PATIENT.
MDR-3009897021-2020-00186 SUBMITTED ON 06-MAY-2020 NOTED THE FOLLOWING: B3: DATE OF EVENT: (B)(6) 2020. G5: PMA/510(K): K063692. H8: USAGE OF DEVICE: REUSE. H10: ADDITIONAL MANUFACTURER NARRATIVE: BASED ON INFORMATION PROVIDED, IT CANNOT BE DETERMINED IF THE ALLEGED ALLERGIC REACTION/INFECTION IS RELATED TO THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM. B3: DATE OF EVENT: (B)(6) 2020. G5: PMA/510(K): K160451. H8: USAGE OF DEVICE: INITIAL USE OF DEVICE. H10: BASED ON INFORMATION PROVIDED, IT CANNOT BE DETERMINED IF THE ALLEGED ALLERGIC REACTION/INFECTION IS RELATED TO THE V.A.C.® GRANUFOAM¿ DRESSING. BASED ON THE CORRECTIONS, KCI'S ASSESSMENT REMAINS THE SAME IT CANNOT BE DETERMINED IF THE ALLEGED ALLERGIC REACTION/INFECTION IS RELATED TO THE V.A.C.® GRANUFOAM¿ DRESSING.
ON 26-MAR-2020, THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM WAS TESTED PER QUALITY CONTROL PROCEDURE BY KCI FIELD SERVICE AND THE UNIT PASSED QUALITY CONTROL CHECKS AND MET SPECIFICATIONS. ON (B)(6) 2020, THE DEVICE WAS PLACED WITH THE PATIENT. ON 09-APR-2020, THE DEVICE WAS RETURNED TO KCI. ON 07-OCT-2020, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY KCI QUALITY ENGINEERING AND PASSED QUALITY CONTROL CHECKS AND MET SPECIFICATIONS. INSPECTION AND TESTING OF THE DEVICE DID NOT REVEAL ANY EVIDENCE OF AN OPERATIONAL MALFUNCTION WITH THE UNIT.
DEVICE DISCARDED, IDENTIFIERS NOT KNOWN. UNIQUE IDENTIFIER (UDI) # FOR ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM (B)(4). DEVICE MANUFACTURE DATE FOR ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM SERIAL NUMBER (B)(4): 23-JAN-2020. BASED ON INFORMATION PROVIDED, IT CANNOT BE DETERMINED IF THE ALLEGED ALLERGIC REACTION/INFECTION IS RELATED TO THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM. THIS EVENT IS BEING REPORTED AS A POSSIBLE USER ERROR AS THE PATIENT STATED A SKIN PREP WAS NOT APPLIED AND THAT ALLEGEDLY CAUSED THE INFECTION/REACTION. THERE HAVE BEEN SEVERAL ATTEMPTS MADE TO GATHER ADDITIONAL INFORMATION, BUT THERE HAS BEEN NO RESPONSE. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: INFECTED WOUNDS: INFECTED WOUNDS SHOULD BE MONITORED CLOSELY AND MAY REQUIRE MORE FREQUENT DRESSING CHANGES THAN NON-INFECTED WOUNDS, DEPENDENT UPON FACTORS SUCH AS WOUND CONDITIONS, TREATMENT GOALS. REFER TO DRESSING APPLICATION INSTRUCTIONS (FOUND IN V.A.C.® DRESSING CARTONS) FOR DETAILS REGARDING DRESSING CHANGE FREQUENCY. AS WITH ANY WOUND TREATMENT, CLINICIANS AND PATIENTS/CAREGIVERS SHOULD FREQUENTLY MONITOR THE PATIENT'S WOUND, PERIWOUND TISSUE AND EXUDATE FOR SIGNS OF INFECTION, WORSENING INFECTION, OR OTHER COMPLICATIONS. SOME SIGNS OF INFECTION ARE FEVER, TENDERNESS, REDNESS, SWELLING, ITCHING, RASH, INCREASED WARMTH IN THE WOUND OR PERIWOUND AREA, PURULENT DISCHARGE OR STRONG ODOR. INFECTION CAN BE SERIOUS, AND CAN LEAD TO COMPLICATIONS SUCH AS PAIN, DISCOMFORT, FEVER, GANGRENE, TOXIC SHOCK, SEPTIC SHOCK AND/OR FATAL INJURY. SOME SIGNS OR COMPLICATIONS OF SYSTEMIC INFECTION ARE NAUSEA, VOMITING, DIARRHEA, HEADACHE, DIZZINESS, FAINTING, SORE THROAT WITH SWELLING OF THE MUCUS MEMBRANES, DISORIENTATION, HIGH FEVER, REFRACTORY AND/OR ORTHOSTATIC HYPOTENSION OR ERYTHRODERMA (A SUNBURN-LIKE RASH). IF THERE ARE ANY SIGNS OF THE ONSET OF SYSTEMIC INFECTION OR ADVANCING INFECTION AT THE WOUND SITE, CONTACT THE TREATING PHYSICIAN IMMEDIATELY TO DETERMINE IF V.A.C.® THERAPY SHOULD BE DISCONTINUED. PRECAUTIONS THE V.A.C.® THERAPY SYSTEM WILL NOT BE EFFECTIVE IN ADDRESSING COMPLICATIONS ASSOCIATED WITH THE FOLLOWING: ISCHEMIA TO THE INCISION OR INCISION AREA. UNTREATED OR INADEQUATELY TREATED INFECTION. INADEQUATE HEMOSTASIS OF THE INCISION. CELLULITIS OF THE INCISION AREA. MAINTAINING A SEAL FOR DELICATE PERIWOUND TISSUE OR IN AREAS THAT ARE DIFFICULT TO DRESS, APPLY PROTECTIVE SKIN PREPARATION AND FRAME THE WOUND WITH TRANSPARENT FILM OR HYDROCOLLOID DRESSING OR OTHER APPROPRIATE BARRIER. PROTECT PERIWOUND SKIN: CONSIDER USE OF A SKIN PREPARATION PRODUCT TO PROTECT PERIWOUND SKIN. DO NOT ALLOW FOAM TO OVERLAP ONTO INTACT SKIN. PROTECT FRAGILE / FRIABLE PERIWOUND SKIN WITH ADDITIONAL V.A.C.® DRAPE, HYDROCOLLOID OR OTHER TRANSPARENT FILM. MULTIPLE LAYERS OF V.A.C.® DRAPE MAY DECREASE THE MOISTURE VAPOR TRANSMISSION RATE. IF ANY SIGNS OF IRRITATION OR SENSITIVITY TO THE DRAPE, FOAM OR TUBING ASSEMBLY APPEAR, DISCONTINUE USE AND CONSULT A PHYSICIAN.
ON (B)(6) 2020, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT: A SKIN BARRIER WAS NOT USED AND THE PATIENT'S SKIN ALLEGEDLY BECAME INFECTED AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. ON (B)(6) 2020, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT: ON (B)(6) 2020, THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM WAS PLACED ON HOLD DUE TO THE PATIENT ALLEGEDLY EXPERIENCING AN ALLERGIC REACTION TO SOMETHING. NO ADDITIONAL INFORMATION AVAILABLE. ON (B)(6) 2020, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT: THE INFECTION WAS ALLEGEDLY DUE TO THE NURSE NOT APPLYING SKIN PREP AND WAS NOT CAUSED BY V.A.C.® THERAPY. THE PATIENT CONTINUED V.A.C.® THERAPY WITH SKIN PREP APPLIED AND THE WOUND IS HEALING WITHOUT ISSUES. THE V.A.C.® GRANUFOAM¿ DRESSING LOT NUMBER WAS NOT PROVIDED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. A DEVICE EVALUATION OF THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM IS CURRENTLY PENDING COMPLETION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 491239 | V.A.C. GRANUFOAM DRESSING | OMP | OMP | KINETIC CONCEPTS, INC. | VACDSP | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Hospitalization| O | ATARAX| BONIVA| LATUDA| LOPRESSOR| NEURONTIN| NORCO| PREDNISONE| PRINIVIL| PROMETHAZINE| PROTONIX| XANAX| ZOLOFT |