BAND-AID BRAND SHEER BANDAGES
Report
- Report Number
- 8041154-2013-00007
- Event Type
- Injury
- Date Received
- May 31, 2013
- Date of Event
- April 1, 2013
- Report Date
- May 3, 2013
- Manufacturer
- BRAZIL CONSUMER
- Product Code
- KGX
- Removal / Correction Number
- NI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
THE DATE OF THIS SUBMISSION IS 18-JUN-2013. THIS IS FOLLOW UP SUBMISSION FOR THE SECOND PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THIS SUBMISSION IS 8041154-2013-00007. THE MANUFACTURER REPORT NUMBER FOR THE FIRST, THIRD, FOURTH PRODUCT IN THIS CASE ARE 8041154-2013-00006, 8041154-2013-00008 AND 8041154-2013-00009 RESPECTIVELY. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.
THIS IS FOLLOW UP SUBMISSION FOR THE SECOND PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THIS SUBMISSION IS 8041154-2013-00007. THE MANUFACTURER REPORT NUMBER FOR THE FIRST, THIRD, FOURTH PRODUCT IN THIS CASE ARE 8041154-2013-00006, 8041154-2013-00008 AND 8041154-2013-00009 RESPECTIVELY. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.
(B)(4). THIS IS AN INITIAL SUBMISSION FOR THE SECOND PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THIS SUBMISSION IS 8041154-2013-00007. THE MANUFACTURER REPORT NUMBER FOR THE FIRST, THIRD, FOURTH PRODUCT IN THIS CASE ARE 8041154-2013-00006, 8041154-2013-00008 AND 8041154-2013-00009 RESPECTIVELY. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.
THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2013, FROM A (B)(6) FEMALE CONSUMER REPORTING ON SELF FROM THE UNITED STATES. THE MEDICAL HISTORY INCLUDED LUPUS SINCE 1992. OTHER HISTORY INCLUDED ALCOHOL USE, ONCE IN A WHILE. THE CONCOMITANT MEDICATION INCLUDED AN UNSPECIFIED STEROID THERAPY FOR LUPUS. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING JOHNSON AND JOHNSON FIRST AID WATERPROOF PAD, CUTANEOUSLY , ONE BAND-AID AT FIRST THEN TWO BAND-AIDS, TWO TO THREE TIMES PER DAY TO COVER A WOUND (LOT NUMBER 2901B, EXPIRATION DATE UNSPECIFIED), BAND-AID BRAND SHEER BANDAGES, CUTANEOUSLY, ONE BAND-AID AT FIRST THEN TWO BAND-AIDS, TWO TO THREE TIMES PER DAY TO COVER A WOUND (LOT NUMBER 2052B, EXPIRATION DATE UNSPECIFIED), BAND-AID BRAND ADHESIVE BANDAGES FAMILY VARIETY PACK, ONE BAND-AID AT FIRST THEN TWO BAND-AIDS, TWO TO THREE TIMES PER DAY TO COVER A WOUND (LOT NUMBER 3568B, EXPIRATION DATE UNSPECIFIED) AND BAND-AID BRAND ADHESIVE BANDAGES PLUS NEOSPORIN, CUTANEOUSLY, ONE BAND-AID AT FIRST THEN TWO BAND-AIDS, TWO TO THREE TIMES PER DAY TO COVER A WOUND (LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, IN THE FIRST WEEK OF (B)(6) 2013, WHILE REMOVING THE BAND-AIDS, HER SKIN GOT REMOVED AND SHE EXPERIENCED BIGGER WOUND THAN THE ORIGINAL ONE. SHE STATED THAT SHE HAD EXPERIENCED THE SAME EVENT MANY TIMES WITH DIFFERENT TYPES OF BAND-AIDS. SHE ALSO STATED THAT THE BAND-AIDS STUCK SO WELL AND IT TOOK A VERY LONG TIME TO REMOVE. SHE APPLIED JOHNSON'S BABY OIL GEL WITH ALOE AND VITAMIN E, TOPICALLY TO LOOSEN THE BAND-AIDS (LOT NUMBER 1109P, EXPIRATION DATE AND FREQUENCY UNSPECIFIED). SHE STOPPED USING ALL KINDS OF BAND-AIDS IN THE SECOND WEEK OF (B)(6) 2013. AFTER AN UNSPECIFIED DURATION, SHE DEVELOPED AN INFECTION ON THAT WOUND AND WENT TO EMERGENCY ROOM ON (B)(6) 2013 TO HAVE THE INFECTION LANCED WHERE A SAMPLE OF WOUND WAS TESTED AND FOUND POSITIVE FOR (B)(6). THE ACTION TAKEN WITH JOHNSON'S BABY OIL GEL WITH ALOE AND VITAMIN E WAS UNKNOWN. THE EVENT WAS RESOLVING. SAMPLE FOR JOHNSON AND JOHNSON FIRST AID WATERPROOF PAD WAS NOT RECEIVED. BATCH RECORD REVIEW REPORT DISCLOSED THAT ALL PROCESSES IN PLACE AT TIME OF MANUFACTURING MET SPECIFICATIONS FOR CORRESPONDING MANUFACTURED LOT 2901B AND NO ABNORMALITIES WERE FOUND. REVIEW OF RELATED PRODUCT CHANGES INCLUDING ALL RELATED DESIGN/FORMULA, PACKAGING/LABELING CHANGES WAS PERFORMED AND NO ISSUES IDENTIFIED. REVIEW OF MANUFACTURING/FACILITY ISSUES INCLUDING REVIEW OF RELATED FACILITY NON-CONFORMANCES/DEVIATIONS WAS PERFORMED AND NO DEVIATIONS IDENTIFIED. VISUAL INSPECTION OF RETAIN SAMPLE REVEALED NO DEVIATIONS AND APPEARED TO BE TYPICAL OF THE PRODUCT. THIS COMPLAINT COULD NOT BE CONFIRMED BASED ON AN ACCEPTABLE SITE REVIEW AND NO ADVERSE TRENDS. ROOT CAUSE AND DISPOSITION WERE UNDETERMINED. COMPLAINT TRENDS WOULD CONTINUE TO BE MONITORED. THIS REPORT WAS ASSESSED AS SERIOUS (REQUIRED INTERVENTION). THE COMPANY CAUSALITY FOR JOHNSON'S BABY OIL GEL WITH ALOE AND VITAMIN E WAS ASSESSED AS DOUBTFUL AND FOR THE DEVICES, ASSESSED AS POSSIBLE. THIS REPORT WAS CONSIDERED A NON REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.
THIS SPONTANEOUS REPORT WAS RECEIVED ON 03-MAY-2013, FROM A (B)(6) YEAR-OLD CAUCASIAN FEMALE CONSUMER REPORTING ON SELF FROM THE UNITED STATES. THE MEDICAL HISTORY INCLUDED LUPUS SINCE 1992. OTHER HISTORY INCLUDED ALCOHOL USE, ONCE IN A WHILE. THE CONCOMITANT MEDICATION INCLUDED AN UNSPECIFIED STEROID THERAPY FOR LUPUS. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING JOHNSON AND JOHNSON FIRST AID WATERPROOF PAD, CUTANEOUSLY , ONE BAND-AID AT FIRST THEN TWO BAND-AIDS, TWO TO THREE TIMES PER DAY TO COVER A WOUND (LOT NUMBER 2901B, EXPIRATION DATE UNSPECIFIED), BAND-AID BRAND SHEER BANDAGES, CUTANEOUSLY, ONE BAND-AID AT FIRST THEN TWO BAND-AIDS, TWO TO THREE TIMES PER DAY TO COVER A WOUND (LOT NUMBER 2052B, EXPIRATION DATE UNSPECIFIED), BAND-AID BRAND ADHESIVE BANDAGES FAMILY VARIETY PACK, ONE BAND-AID AT FIRST THEN TWO BAND-AIDS, TWO TO THREE TIMES PER DAY TO COVER A WOUND (LOT NUMBER 3568B, EXPIRATION DATE UNSPECIFIED) AND BAND-AID BRAND ADHESIVE BANDAGES PLUS NEOSPORIN, CUTANEOUSLY, ONE BAND-AID AT FIRST THEN TWO BAND-AIDS, TWO TO THREE TIMES PER DAY TO COVER A WOUND (LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, IN THE FIRST WEEK OF (B)(6) 2013, WHILE REMOVING THE BAND-AIDS, HER SKIN GOT REMOVED AND SHE EXPERIENCED BIGGER WOUND THAN THE ORIGINAL ONE. SHE STATED THAT SHE HAD EXPERIENCED THE SAME EVENT MANY TIMES WITH DIFFERENT TYPES OF BAND-AIDS. SHE ALSO STATED THAT THE BAND-AIDS STUCK SO WELL AND IT TOOK A VERY LONG TIME TO REMOVE. SHE APPLIED JOHNSON'S BABY OIL GEL WITH ALOE AND VITAMIN E, TOPICALLY TO LOOSEN THE BAND-AIDS (LOT NUMBER 1109P, EXPIRATION DATE AND FREQUENCY UNSPECIFIED). SHE STOPPED USING ALL KINDS OF BAND-AIDS IN THE SECOND WEEK OF (B)(6) 2013. AFTER AN UNSPECIFIED DURATION, SHE DEVELOPED AN INFECTION ON THAT WOUND AND WENT TO EMERGENCY ROOM ON 04-MAY-2013 TO HAVE THE INFECTION LANCED WHERE A SAMPLE OF WOUND WAS TESTED AND FOUND POSITIVE FOR MRSA INFECTION (METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS). THE ACTION TAKEN WITH JOHNSON'S BABY OIL GEL WITH ALOE AND VITAMIN E WAS UNKNOWN. THE EVENT WAS RESOLVING. SAMPLE FOR JOHNSON AND JOHNSON FIRST AID WATERPROOF PAD WAS NOT RECEIVED. BATCH RECORD REVIEW REPORT DISCLOSED THAT ALL PROCESSES IN PLACE AT TIME OF MANUFACTURING MET SPECIFICATIONS FOR CORRESPONDING MANUFACTURED LOT 2901B AND NO ABNORMALITIES WERE FOUND. REVIEW OF RELATED PRODUCT CHANGES INCLUDING ALL RELATED DESIGN/FORMULA, PACKAGING/LABELING CHANGES WAS PERFORMED AND NO ISSUES IDENTIFIED. REVIEW OF MANUFACTURING/FACILITY ISSUES INCLUDING REVIEW OF RELATED FACILITY NON-CONFORMANCES/DEVIATIONS WAS PERFORMED AND NO DEVIATIONS IDENTIFIED. VISUAL INSPECTION OF RETAIN SAMPLE REVEALED NO DEVIATIONS AND APPEARED TO BE TYPICAL OF THE PRODUCT. THIS COMPLAINT COULD NOT BE CONFIRMED BASED ON AN ACCEPTABLE SITE REVIEW AND NO ADVERSE TRENDS. ROOT CAUSE AND DISPOSITION WERE UNDETERMINED. COMPLAINT TRENDS WOULD CONTINUE TO BE MONITORED. THIS REPORT WAS ASSESSED AS SERIOUS (REQUIRED INTERVENTION). THE COMPANY CAUSALITY FOR JOHNSON'S BABY OIL GEL WITH ALOE AND VITAMIN E WAS ASSESSED AS DOUBTFUL AND FOR THE DEVICES, ASSESSED AS POSSIBLE. THIS REPORT WAS CONSIDERED A NON REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON 10-JUN-2013. THE SAMPLE BAND-AID BRAND SHEER BANDAGE WAS NOT RECEIVED. BATCH RECORD REVIEW REPORT DISCLOSED THAT ALL PROCESSES WERE IN PLACE AT TIME OF MANUFACTURING MET SPECIFICATIONS AND NO ABNORMALITIES FOUND. REVIEW OF RELATED PRODUCT CHANGES AND MANUFACTURING OR FACILITY ISSUES REVEALED NO ISSUES OR DEVIATIONS. VISUAL INSPECTION OF RETAIN SAMPLE REVEALED NO DEVIATIONS AND APPEARED TO BE TYPICAL OF THE PRODUCT. THIS COMPLAINT COULD NOT BE CONFIRMED BASED ON AN ACCEPTABLE SITE REVIEW AND NO ADVERSE TRENDS. ROOT CAUSE AND DISPOSITION WERE UNDETERMINED. MONITORING OF COMPLAINT TRENDS WOULD CONTINUE. THIS REPORT REMAINS SERIOUS (REQUIRED INTERVENTION).THIS REPORT REMAINS A NON REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.
THIS SPONTANEOUS REPORT WAS RECEIVED ON 03-MAY-2013, FROM A (B)(6) CAUCASIAN FEMALE CONSUMER REPORTING ON SELF FROM THE UNITED STATES. THE MEDICAL HISTORY INCLUDED LUPUS SINCE 1992. OTHER HISTORY INCLUDED ALCOHOL USE, ONCE IN A WHILE. THE CONCOMITANT MEDICATION INCLUDED AN UNSPECIFIED STEROID THERAPY FOR LUPUS. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING JOHNSON AND JOHNSON FIRST AID WATERPROOF PAD, CUTANEOUSLY , ONE BAND-AID AT FIRST THEN TWO BAND-AIDS, TWO TO THREE TIMES PER DAY TO COVER A WOUND (LOT NUMBER 2901B, EXPIRATION DATE UNSPECIFIED), BAND-AID BRAND SHEER BANDAGES, CUTANEOUSLY, ONE BAND-AID AT FIRST THEN TWO BAND-AIDS, TWO TO THREE TIMES PER DAY TO COVER A WOUND (LOT NUMBER 2052B, EXPIRATION DATE UNSPECIFIED), BAND-AID BRAND ADHESIVE BANDAGES FAMILY VARIETY PACK, ONE BAND-AID AT FIRST THEN TWO BAND-AIDS, TWO TO THREE TIMES PER DAY TO COVER A WOUND (LOT NUMBER 3568B, EXPIRATION DATE UNSPECIFIED) AND BAND-AID BRAND ADHESIVE BANDAGES PLUS NEOSPORIN, CUTANEOUSLY, ONE BAND-AID AT FIRST THEN TWO BAND-AIDS, TWO TO THREE TIMES PER DAY TO COVER A WOUND (LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, IN THE FIRST WEEK OF (B)(6) 2013, WHILE REMOVING THE BAND-AIDS, HER SKIN GOT REMOVED AND SHE EXPERIENCED BIGGER WOUND THAN THE ORIGINAL ONE. SHE STATED THAT SHE HAD EXPERIENCED THE SAME EVENT MANY TIMES WITH DIFFERENT TYPES OF BAND-AIDS. SHE ALSO STATED THAT THE BAND-AIDS STUCK SO WELL AND IT TOOK A VERY LONG TIME TO REMOVE. SHE APPLIED JOHNSON'S BABY OIL GEL WITH ALOE AND VITAMIN E, TOPICALLY TO LOOSEN THE BAND-AIDS (LOT NUMBER 1109P, EXPIRATION DATE AND FREQUENCY UNSPECIFIED). SHE STOPPED USING ALL KINDS OF BAND-AIDS IN THE SECOND WEEK OF (B)(6) 2013. AFTER AN UNSPECIFIED DURATION, SHE DEVELOPED AN INFECTION ON THAT WOUND AND WENT TO EMERGENCY ROOM ON (B)(6) 2013 TO HAVE THE INFECTION LANCED WHERE A SAMPLE OF WOUND WAS TESTED AND FOUND POSITIVE FOR (B)(6) INFECTION ((B)(6)). THE ACTION TAKEN WITH JOHNSON'S BABY OIL GEL WITH ALOE AND VITAMIN E WAS UNKNOWN. THE EVENT WAS RESOLVING. SAMPLE FOR JOHNSON AND JOHNSON FIRST AID WATERPROOF PAD WAS NOT RECEIVED. BATCH RECORD REVIEW REPORT DISCLOSED THAT ALL PROCESSES IN PLACE AT TIME OF MANUFACTURING MET SPECIFICATIONS FOR CORRESPONDING MANUFACTURED LOT 2901B AND NO ABNORMALITIES WERE FOUND. REVIEW OF RELATED PRODUCT CHANGES INCLUDING ALL RELATED DESIGN/FORMULA, PACKAGING/LABELING CHANGES WAS PERFORMED AND NO ISSUES IDENTIFIED. REVIEW OF MANUFACTURING/FACILITY ISSUES INCLUDING REVIEW OF RELATED FACILITY NON-CONFORMANCES/DEVIATIONS WAS PERFORMED AND NO DEVIATIONS IDENTIFIED. VISUAL INSPECTION OF RETAIN SAMPLE REVEALED NO DEVIATIONS AND APPEARED TO BE TYPICAL OF THE PRODUCT. THIS COMPLAINT COULD NOT BE CONFIRMED BASED ON AN ACCEPTABLE SITE REVIEW AND NO ADVERSE TRENDS. ROOT CAUSE AND DISPOSITION WERE UNDETERMINED. COMPLAINT TRENDS WOULD CONTINUE TO BE MONITORED. THIS REPORT WAS ASSESSED AS SERIOUS (REQUIRED INTERVENTION). THE COMPANY CAUSALITY FOR JOHNSON'S BABY OIL GEL WITH ALOE AND VITAMIN E WAS ASSESSED AS DOUBTFUL AND FOR THE DEVICES, ASSESSED AS POSSIBLE. THIS REPORT WAS CONSIDERED A NON REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON 10-JUN-2013. THE SAMPLE BAND-AID BRAND SHEER BANDAGE WAS NOT RECEIVED. BATCH RECORD REVIEW REPORT DISCLOSED THAT ALL PROCESSES WERE IN PLACE AT TIME OF MANUFACTURING MET SPECIFICATIONS AND NO ABNORMALITIES FOUND. REVIEW OF RELATED PRODUCT CHANGES AND MANUFACTURING OR FACILITY ISSUES REVEALED NO ISSUES OR DEVIATIONS. VISUAL INSPECTION OF RETAIN SAMPLE REVEALED NO DEVIATIONS AND APPEARED TO BE TYPICAL OF THE PRODUCT. THIS COMPLAINT COULD NOT BE CONFIRMED BASED ON AN ACCEPTABLE SITE REVIEW AND NO ADVERSE TRENDS. ROOT CAUSE AND DISPOSITION WERE UNDETERMINED. MONITORING OF COMPLAINT TRENDS WOULD CONTINUE. THIS REPORT REMAINS SERIOUS (REQUIRED INTERVENTION).THIS REPORT REMAINS A NON REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON 19-JUN-2013. LOT NUMBER FOR BAND-AID BRAND ADHESIVE BANDAGES PLUS NEOSPORIN WAS NOT PROVIDED AND A SAMPLE WAS NOT RECEIVED. LOT NUMBER PROVIDED FOR BAND-AID BRAND ADHESIVE BANDAGES FAMILY VARIETY PACK WAS INVALID AND A SAMPLE WAS NOT RECEIVED. MANUFACTURING DATA WERE REVIEWED AND NO ABNORMALITIES WERE FOUND. THE FINAL PRODUCT FOR ALL LOTS WAS INSPECTED FOR CONFORMANCE BEFORE APPROVAL AND WAS IN CONFORMANCE BEFORE RELEASE, MEETING ALL SPECIFICATION REQUIREMENTS. A REVIEW OF THE COMPLAINT DATA REVEALED NO ADVERSE TRENDS AND NO TRENDS INVOLVING THIS LOT NUMBER. THIS COMPLAINT COULD NOT BE CONFIRMED BASED ON AN ACCEPTABLE SITE REVIEW AND NO ADVERSE TRENDS. ROOT CAUSE AND DISPOSITION WERE UNDETERMINED. 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 |
|---|---|---|---|---|---|---|---|
| 240771 | BAND-AID BRAND SHEER BANDAGES | ADHESIVE BANDAGE | KGX | BRAZIL CONSUMER | 8137004984 | 2052B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |