BAB TOUGH STRIPS BNS 20+6
Report
- Report Number
- 8041154-2013-00003
- Event Type
- Injury
- Date Received
- February 15, 2013
- Report Date
- January 23, 2013
- Manufacturer
- BRAZIL CONSUMER
- Product Code
- KGX
- Removal / Correction Number
- NI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
(B)(4). THIS IS A FOLLOW UP SUBMISSION FOR THE THIRD PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THIS SUBMISSION IS 8041154-2013-00003. THE MANUFACTURER REPORT NUMBERS FOR THE FIRST, SECOND AND FOURTH PRODUCT IN THIS CASE ARE 8041154-2013-00001, 8041154-2013-00002 AND 8041154-2013-00004 RESPECTIVELY. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.
THE DATE OF THIS SUBMISSION IS (B)(4) 2013. THIS IS A FOLLOW UP SUBMISSION FOR THE THIRD PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THIS SUBMISSION IS 8041154-2013-00003. THE MANUFACTURER REPORT NUMBERS FOR THE FIRST, SECOND AND FOURTH PRODUCT IN THIS CASE ARE 8041154-2013-00001, 8041154-2013-00002 AND 8041154-2013-00004 RESPECTIVELY. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.
THE DATE OF THIS SUBMISSION IS (B)(6) 2013. THIS IS A FOLLOW UP SUBMISSION FOR THE THIRD PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THIS SUBMISSION IS 8041154-2013-00003. THE MANUFACTURER REPORT NUMBERS FOR THE FIRST, SECOND AND FOURTH PRODUCT IN THIS CASE ARE 8041154-2013-00001, 8041154-2013-00002 AND 8041154-2013-00004 RESPECTIVELY. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.
THE DATE OF THIS SUBMISSION IS (B)(4) 2013. THIS IS AN INITIAL SUBMISSION FOR THE THIRD PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THIS SUBMISSION IS 8041154-2013-00003. THE MANUFACTURER REPORT NUMBERS FOR THE FIRST, SECOND AND FOURTH PRODUCT IN THIS CASE ARE 8041154-2013-00001, 8041154-2013-00002 AND 8041154-2013-00004 RESPECTIVELY. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.
THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013, FROM A (B)(6) FEMALE CONSUMER REPORTING ON SELF FROM THE UNITED STATES. THE MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, COUPLE OF MONTHS AGO, THE CONSUMER STARTED USING, BAND AID BRAND ADHESIVE BANDAGES TOUGH STRIPS, CUTANEOUSLY, FOUR OR FIVE PER DAY TO COVER BLEEDING AND CUTS (LOT NUMBER 22621B AND EXPIRATION DATE UNSPECIFIED) BAND AID BRAND ADHESIVE BANDAGES FLEXIBLE FABRIC, CUTANEOUSLY, ALMOST ALL BAND AIDS, FOUR OR FIVE PER DAY, TO COVER BLEEDING AND CUTS (LOT NUMBER 2201S AND EXPIRATION DATE UNSPECIFIED), DERMICARE HYPO ALLERGENIC PAPER TAPE, CUTANEOUSLY, ENOUGH TO WRAP AROUND THE GAUZE, A COUPLE TIMES, TO HOLD ON GAUZE THAT WAS COVERING A WOUND FROM A BAND-AID (LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). SHE STATED THAT SINCE LAST COUPLE OF MONTHS UPON USING ALL THE ABOVE BAND-AIDS HER SKIN WAS TEARING OFF DUE TO WHICH SHE WAS BLEEDING AND SHE ALSO DEVELOPED SCARS. AFTER AN UNSPECIFIED DURATION, ON (B)(6) 2013, SHE STARTED USING BAND AID BRAND ADHESIVE BANDAGES TOUGH STRIPS, CUTANEOUSLY, ALMOST ALL BAND AIDS, FOUR OR FIVE PER DAY, TO COVER BLEEDING AND CUTS (LOT NUMBER 1021B AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, SHE AGAIN NOTICED HER SKIN WAS TEARING OFF DUE TO WHICH SHE WAS BLEEDING AND SHE ALSO DEVELOPED SCARS. HER SKIN LOOKED BLACK AND BLUE WITH THE USE OF ALL THE ABOVE BAND-AIDS OTHER THAN DERMICARE HYPO ALLERGENIC PAPER TAPE AND HER SKIN BRUISED WITH THE USE OF DERMICARE HYPO ALLERGENIC PAPER TAPE. SHE MENTIONED THAT FOR THE LAST COUPLE OF MONTHS SHE HAD BEEN EXPERIENCING THE SAME EVENTS. SHE VISITED HER DOCTOR ONCE LAST MONTH AND AGAIN ABOUT THREE WEEKS AGO. DURING HER LAST VISIT HER DOCTOR HAD TO PERFORM CAUTERIZATION. IT WAS FURTHER STATED THAT SHE WOULD HAVE TO GO BACK TO THE DOCTOR FOR HER SCARS WHICH PROBABLY WOULD NEED SKIN GRAFT. AFTER AN UNSPECIFIED DURATION, SHE DISCONTINUED ALL THE ABOVE BAND-AIDS OTHER THAN DERMICARE HYPO ALLERGENIC PAPER TAPE. THE EVENTS DID NOT RESOLVE. THE REPORT WAS ASSESSED AS SERIOUS (REQUIRED INTERVENTION). THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE. THIS REPORT WAS CONSIDERED A NON REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013. THE LOT NUMBER OF BAND AID BRAND ADHESIVE BANDAGES TOUGH STRIPS WAS UPDATED FROM 22621B TO 2621B. QUALITY INVESTIGATION FOR BAND AID BRAND ADHESIVE BANDAGES TOUGH STRIPS, LOT NUMBERS 2621B AND 1021B RESPECTIVELY REVEALED AN INCREASE IN COMPLAINT VOLUME. LOT NUMBER WAS NOT PROVIDED FOR DERMICARE HYPO ALLERGENIC PAPER TAPE. COMPLAINT TRENDS FOR ALL THE THREE DEVICES WOULD CONTINUE TO BE MONITORED AND THESE COMPLAINTS COULD NOT BE CONFIRMED BASED ON AN ACCEPTABLE SITE REVIEW AND NO ADVERSE TRENDS. ROOT CAUSE AND DISPOSITION FOR THE THREE DEVICES WERE UNDETERMINED. THIS REPORT REMAINS SERIOUS (REQUIRED INTERVENTION). THIS REPORT REMAINS A NON REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.
THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A (B)(6) FEMALE CONSUMER REPORTING ON SELF FROM THE UNITED STATES. THE MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, COUPLE OF MONTHS AGO, THE CONSUMER STARTED USING, BAND AID BRAND ADHESIVE BANDAGES TOUGH STRIPS, CUTANEOUSLY, FOUR OR FIVE PER DAY TO COVER BLEEDING AND CUTS (LOT NUMBER 22621B AND EXPIRATION DATE UNSPECIFIED) BAND AID BRAND ADHESIVE BANDAGES FLEXIBLE FABRIC, CUTANEOUSLY, ALMOST ALL BAND AIDS, FOUR OR FIVE PER DAY, TO COVER BLEEDING AND CUTS (LOT NUMBER 2201S AND EXPIRATION DATE UNSPECIFIED), DERMICARE HYPO ALLERGENIC PAPER TAPE, CUTANEOUSLY, ENOUGH TO WRAP AROUND THE GAUZE, A COUPLE TIMES, TO HOLD ON GAUZE THAT WAS COVERING A WOUND FROM A BAND-AID (LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). SHE STATED THAT SINCE LAST COUPLE OF MONTHS UPON USING ALL THE ABOVE BAND-AIDS HER SKIN WAS TEARING OFF DUE TO WHICH SHE WAS BLEEDING AND SHE ALSO DEVELOPED SCARS. AFTER AN UNSPECIFIED DURATION, ON (B)(6) 2013 SHE STARTED USING BAND AID BRAND ADHESIVE BANDAGES TOUGH STRIPS, CUTANEOUSLY, ALMOST ALL BAND AIDS, FOUR OR FIVE PER DAY, TO COVER BLEEDING AND CUTS (LOT NUMBER 1021B AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, SHE AGAIN NOTICED HER SKIN WAS TEARING OFF DUE TO WHICH SHE WAS BLEEDING AND SHE ALSO DEVELOPED SCARS. HER SKIN LOOKED BLACK AND BLUE WITH THE USE OF ALL THE ABOVE BAND-AIDS OTHER THAN DERMICARE HYPO ALLERGENIC PAPER TAPE AND HER SKIN BRUISED WITH THE USE OF DERMICARE HYPO ALLERGENIC PAPER TAPE. SHE MENTIONED THAT FOR THE LAST COUPLE OF MONTHS SHE HAD BEEN EXPERIENCING THE SAME EVENTS. SHE VISITED HER DOCTOR ONCE LAST MONTH AND AGAIN ABOUT THREE WEEKS AGO. DURING HER LAST VISIT HER DOCTOR HAD TO PERFORM CAUTERIZATION. IT WAS FURTHER STATED THAT SHE WOULD HAVE TO GO BACK TO THE DOCTOR FOR HER SCARS WHICH PROBABLY WOULD NEED SKIN GRAFT. AFTER AN UNSPECIFIED DURATION, SHE DISCONTINUED ALL THE ABOVE BAND-AIDS OTHER THAN DERMICARE HYPO ALLERGENIC PAPER TAPE. THE EVENTS DID NOT RESOLVE. THE REPORT WAS ASSESSED AS SERIOUS (REQUIRED INTERVENTION). THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE. THIS REPORT WAS CONSIDERED A NON REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013. THE LOT NUMBER OF BAND AID BRAND ADHESIVE BANDAGES TOUGH STRIPS WAS UPDATED FROM 22621B TO 2621B. QUALITY INVESTIGATION FOR BAND AID BRAND ADHESIVE BANDAGES TOUGH STRIPS, LOT NUMBERS 2621B AND 1021B RESPECTIVELY REVEALED AN INCREASE IN COMPLAINT VOLUME. LOT NUMBER WAS NOT PROVIDED FOR DERMICARE HYPO ALLERGENIC PAPER TAPE. COMPLAINT TRENDS FOR ALL THE THREE DEVICES WOULD CONTINUE TO BE MONITORED AND THESE COMPLAINTS COULD NOT BE CONFIRMED BASED ON AN ACCEPTABLE SITE REVIEW AND NO ADVERSE TRENDS. ROOT CAUSE AND DISPOSITION FOR THE THREE DEVICES WERE UNDETERMINED. THIS REPORT REMAINS SERIOUS (REQUIRED INTERVENTION). THIS REPORT REMAINS A NON REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013. ON AN UNSPECIFIED DATE,THE CONSUMER CONSULTED A HEALTH CARE PROFESSIONAL WHO TOLD HER SKIN WAS TORN BY THE BAND-AID AND IT REQUIRED CAUTERIZATION TWICE. HER EVENTS WERE TREATED BY COVERING THE WOUND WITH UNSPECIFIED GAUZE BANDAGE AND SALVE (MEDICAL OINTMENT) FOR TWO WEEKS. SHE MENTIONED THAT THE EVENT OF SCARRING DID NOT RESOLVE. RETURNED SAMPLE WAS NOT RECEIVED FOR BAND-AID BRAND ADHESIVE BANDAGES FLEXIBLE FABRIC. A REVIEW OF THE COMPLAINTS REVEALED AN INCREASE IN COMPLAINT VOLUME FOR LOT NUMBER 2201S. A BATCH RECORD REVIEW WAS PERFORMED AND NO NON-CONFORMANCES OR DEVIATIONS WERE NOTED,ALL RECORDS WERE FOUND TO BE ACCEPTABLE. RETAIN SAMPLES MET SPECIFICATION. A MANUFACTURING SITE REVIEW WAS COMPLETED AND THERE WERE NO DEVIATIONS OR PRODUCT RELATED CHANGES FOR ONE YEAR PRIOR TO THE MANUFACTURE OF THIS LOT. THE ROOT CAUSE AND DISPOSITION WERE UNDETERMINED. NO ADVERSE TRENDS WERE IDENTIFIED DURING THE COMPLAINT INVESTIGATION. COMPLAINT TRENDS WOULD CONTINUE TO BE MONITORED. THIS REPORT REMAINS SERIOUS. THIS REPORT REMAINS A NON REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.
THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2013 FROM A (B)(6) CAUCASIAN FEMALE CONSUMER REPORTING ON SELF FROM THE UNITED STATES. THE MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, COUPLE OF MONTHS AGO, THE CONSUMER STARTED USING, (B)(4) BRAND ADHESIVE BANDAGES TOUGH STRIPS, CUTANEOUSLY, FOUR OR FIVE PER DAY TO COVER BLEEDING AND CUTS (LOT NUMBER 22621B AND EXPIRATION DATE UNSPECIFIED) (B)(4) BRAND ADHESIVE BANDAGES FLEXIBLE FABRIC, CUTANEOUSLY, ALMOST ALL (B)(4), FOUR OR FIVE PER DAY, TO COVER BLEEDING AND CUTS (LOT NUMBER 2201S AND EXPIRATION DATE UNSPECIFIED), DERMICARE HYPO ALLERGENIC PAPER TAPE, CUTANEOUSLY, ENOUGH TO WRAP AROUND THE GAUZE, A COUPLE TIMES, TO HOLD ON GAUZE THAT WAS COVERING A WOUND FROM A (B)(4) (LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). SHE STATED THAT SINCE LAST COUPLE OF MONTHS UPON USING ALL THE ABOVE (B)(4) HER SKIN WAS TEARING OFF DUE TO WHICH SHE WAS BLEEDING AND SHE ALSO DEVELOPED SCARS. AFTER AN UNSPECIFIED DURATION, ON (B)(6) 2013 SHE STARTED USING (B)(4) BRAND ADHESIVE BANDAGES TOUGH STRIPS, CUTANEOUSLY, ALMOST ALL (B)(4), FOUR OR FIVE PER DAY, TO COVER BLEEDING AND CUTS (LOT NUMBER 1021B AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, SHE AGAIN NOTICED HER SKIN WAS TEARING OFF DUE TO WHICH SHE WAS BLEEDING AND SHE ALSO DEVELOPED SCARS. HER SKIN LOOKED BLACK AND BLUE WITH THE USE OF ALL THE ABOVE (B)(4) OTHER THAN DERMICARE HYPO ALLERGENIC PAPER TAPE AND HER SKIN BRUISED WITH THE USE OF DERMICARE HYPO ALLERGENIC PAPER TAPE. SHE MENTIONED THAT FOR THE LAST COUPLE OF MONTHS SHE HAD BEEN EXPERIENCING THE SAME EVENTS. SHE VISITED HER DOCTOR ONCE LAST MONTH AND AGAIN ABOUT THREE WEEKS AGO. DURING HER LAST VISIT HER DOCTOR HAD TO PERFORM CAUTERIZATION. IT WAS FURTHER STATED THAT SHE WOULD HAVE TO GO BACK TO THE DOCTOR FOR HER SCARS WHICH PROBABLY WOULD NEED SKIN GRAFT. AFTER AN UNSPECIFIED DURATION, SHE DISCONTINUED ALL THE ABOVE (B)(4) OTHER THAN DERMICARE HYPO ALLERGENIC PAPER TAPE. THE EVENTS DID NOT RESOLVE. THE REPORT WAS ASSESSED AS SERIOUS (REQUIRED INTERVENTION). THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE. THIS REPORT WAS CONSIDERED A NON REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.
THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A (B)(6) FEMALE CONSUMER REPORTING ON SELF FROM THE UNITED STATES. THE MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, COUPLE OF MONTHS AGO, THE CONSUMER STARTED USING, BAND AID BRAND ADHESIVE BANDAGES TOUGH STRIPS, CUTANEOUSLY, FOUR OR FIVE PER DAY TO COVER BLEEDING AND CUTS (LOT NUMBER 22621B AND EXPIRATION DATE UNSPECIFIED) BAND AID BRAND ADHESIVE BANDAGES FLEXIBLE FABRIC, CUTANEOUSLY, ALMOST ALL BAND AIDS, FOUR OR FIVE PER DAY, TO COVER BLEEDING AND CUTS (LOT NUMBER 2201S AND EXPIRATION DATE UNSPECIFIED), DERMICARE HYPO ALLERGENIC PAPER TAPE, CUTANEOUSLY, ENOUGH TO WRAP AROUND THE GAUZE, A COUPLE TIMES, TO HOLD ON GAUZE THAT WAS COVERING A WOUND FROM A BAND-AID (LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). SHE STATED THAT SINCE LAST COUPLE OF MONTHS UPON USING ALL THE ABOVE BAND-AIDS HER SKIN WAS TEARING OFF DUE TO WHICH SHE WAS BLEEDING AND SHE ALSO DEVELOPED SCARS. AFTER AN UNSPECIFIED DURATION, ON (B)(6) 2013 SHE STARTED USING BAND AID BRAND ADHESIVE BANDAGES TOUGH STRIPS, CUTANEOUSLY, ALMOST ALL BAND AIDS, FOUR OR FIVE PER DAY, TO COVER BLEEDING AND CUTS (LOT NUMBER 1021B AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, SHE AGAIN NOTICED HER SKIN WAS TEARING OFF DUE TO WHICH SHE WAS BLEEDING AND SHE ALSO DEVELOPED SCARS. HER SKIN LOOKED BLACK AND BLUE WITH THE USE OF ALL THE ABOVE BAND-AIDS OTHER THAN DERMICARE HYPO ALLERGENIC PAPER TAPE AND HER SKIN BRUISED WITH THE USE OF DERMICARE HYPO ALLERGENIC PAPER TAPE. SHE MENTIONED THAT FOR THE LAST COUPLE OF MONTHS SHE HAD BEEN EXPERIENCING THE SAME EVENTS. SHE VISITED HER DOCTOR ONCE LAST MONTH AND AGAIN ABOUT THREE WEEKS AGO. DURING HER LAST VISIT HER DOCTOR HAD TO PERFORM CAUTERIZATION. IT WAS FURTHER STATED THAT SHE WOULD HAVE TO GO BACK TO THE DOCTOR FOR HER SCARS WHICH PROBABLY WOULD NEED SKIN GRAFT. AFTER AN UNSPECIFIED DURATION, SHE DISCONTINUED ALL THE ABOVE BAND-AIDS OTHER THAN DERMICARE HYPO ALLERGENIC PAPER TAPE. THE EVENTS DID NOT RESOLVE. THE REPORT WAS ASSESSED AS SERIOUS (REQUIRED INTERVENTION). THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE. THIS REPORT WAS CONSIDERED A NON REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013. THE LOT NUMBER OF BAND AID BRAND ADHESIVE BANDAGES TOUGH STRIPS WAS UPDATED FROM 22621B TO 2621B. QUALITY INVESTIGATION FOR BAND AID BRAND ADHESIVE BANDAGES TOUGH STRIPS, LOT NUMBERS 2621B AND 1021B RESPECTIVELY REVEALED AN INCREASE IN COMPLAINT VOLUME. LOT NUMBER WAS NOT PROVIDED FOR DERMICARE HYPO ALLERGENIC PAPER TAPE. COMPLAINT TRENDS FOR ALL THE THREE DEVICES WOULD CONTINUE TO BE MONITORED AND THESE COMPLAINTS COULD NOT BE CONFIRMED BASED ON AN ACCEPTABLE SITE REVIEW AND NO ADVERSE TRENDS. ROOT CAUSE AND DISPOSITION FOR THE THREE DEVICES WERE UNDETERMINED. THIS REPORT REMAINS SERIOUS (REQUIRED INTERVENTION). THIS REPORT REMAINS A NON REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013. ON AN UNSPECIFIED DATE,THE CONSUMER CONSULTED A HEALTH CARE PROFESSIONAL WHO TOLD HER SKIN WAS TORN BY THE BAND-AID AND IT REQUIRED CAUTERIZATION TWICE. HER EVENTS WERE TREATED BY COVERING THE WOUND WITH UNSPECIFIED GAUZE BANDAGE AND SALVE (MEDICAL OINTMENT) FOR TWO WEEKS. SHE MENTIONED THAT THE EVENT OF SCARRING DID NOT RESOLVE. RETURNED SAMPLE WAS NOT RECEIVED FOR BAND-AID BRAND ADHESIVE BANDAGES FLEXIBLE FABRIC. A REVIEW OF THE COMPLAINTS REVEALED AN INCREASE IN COMPLAINT VOLUME FOR LOT NUMBER 2201S. A BATCH RECORD REVIEW WAS PERFORMED AND NO NON-CONFORMANCES OR DEVIATIONS WERE NOTED, ALL RECORDS WERE FOUND TO BE ACCEPTABLE. RETAIN SAMPLES MET SPECIFICATION. A MANUFACTURING SITE REVIEW WAS COMPLETED AND THERE WERE NO DEVIATIONS OR PRODUCT RELATED CHANGES FOR ONE YEAR PRIOR TO THE MANUFACTURE OF THIS LOT. THE ROOT CAUSE AND DISPOSITION WERE UNDETERMINED. NO ADVERSE TRENDS WERE IDENTIFIED DURING THE COMPLAINT INVESTIGATION. COMPLAINT TRENDS WOULD CONTINUE TO BE MONITORED. THIS REPORT REMAINS SERIOUS. THIS REPORT REMAINS A NON REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013. AS PER THE BATCH RECORD REVIEW, ALL PROCESSES WERE IN PLACE AT TIME OF MANUFACTURING AND MET SPECIFICATIONS FOR TOUGH STRIPS (LOT 1021B AND 2621B). THE RETAIN SAMPLES WERE VISUALLY INSPECTED AND NO ABNORMALITIES WERE FOUND. REVIEW OF MANUFACTURING FACILITY, RELATED PRODUCT CHANGES REVEALED NO DEVIATIONS. A REVIEW OF THE COMPLAINT DATA REVEALED AN INCREASE IN COMPLAINT VOLUME HOWEVER, MULTIPLE CONSUMERS REPORTED WITH THE SAME NAME OR SAME ADDRESS. FOR PAPER TAPE MANUFACTURING DATA WERE REVIEWED, AND NO ABNORMALITIES WERE FOUND. THE FINAL PRODUCT FOR ALL LOTS PRODUCED WAS INSPECTED FOR CONFORMANCE AND WAS IN CONFORMANCE BEFORE RELEASE, MEETING ALL SPECIFICATION REQUIREMENTS. COMPLAINT TRENDS WOULD CONTINUE TO BE MONITORED FOR THE THREE DEVICES. THIS COMPLAINT COULD NOT BE CONFIRMED BASED ON AN ACCEPTABLE SITE REVIEW AND NO ADVERSE TRENDS. ROOT CAUSE AND DISPOSITION FOR THE THREE DEVICES WERE UNDETERMINED. THE CONSUMER STATED THAT SHE UNDERWENT CAUTERIZATION THREE TIMES. THIS REPORT REMAINS SERIOUS (REQUIRED INTERVENTION). THIS REPORT REMAINS A NON REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 66220 | BAB TOUGH STRIPS BNS 20+6 | ADHESIVE BANDAGE | KGX | BRAZIL CONSUMER | 8137004424 | 1021B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |