BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES
Report
- Report Number
- 2214133-2024-00035
- Event Type
- Injury
- Date Received
- August 22, 2024
- Report Date
- August 2, 2024
- Manufacturer
- JOHNSON & JOHNSON CONSUMER INC
- Product Code
- NAD
- UDI-DI
- 4901730021906
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
JOHNSON & AMP; JOHNSON CONSUMER, INC. IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH JOHNSON & JOHNSON CONSUMER, INC. HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, JOHNSON & JOHNSON CONSUMER, INC. OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, JOHNSON & JOHNSON CONSUMER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A4, A5: PATIENT IDENTIFIER, PATIENT¿S AGE, GENDER, WEIGHT, ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR ONE (BAND AID BRAND KIZU POWER PAD (KPP) REGULAR 10CT AP 4901730021906 4901730021906 APB 4901730021906APB, LOT/CTRL # N/A). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (BAND AID BRAND HYDROSEAL BANDAGES ALL PURPOSE 1CT USA 381371175338 8137117533USA 8137117533USA). D4: UDI #: (B)(4). UPC #: 4901730021906 LOT #: NI EXP DATE: NA. D9: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. HEALTH EFFECT CLINICAL CODE: E040203 REFERS TO, CONSUMER ALLEGED WOUND STARTED TO SMELL STRANGE. THIS MEDWATCH IS FOR REGULAR BAND-AID HYDROSEAL BANDAGE, LOT NUMBER IS UNKNOWN. TWO MED WATCHES (. 2214133-2024-00036) ARE BEING SUBMITTED AS CONSUMER REPORTED USE OF TWO DIFFERENT BOXES WITH TWO DIFFERENT SIZES OF BAND-AIDS WITH THE SAME EVENT DESCRIPTION. SEE MEDWATCH . 2214133-2024-00036. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
CONSUMER REPORTED AN EVENT WITH BAND AID HYDROSEAL BANDAGES. CONSUMER APPLIED REGULAR BAND-AID HYDROSEAL BANDAGES ON A CUT ON THE FINGER AND THE WOUND STARTED TO SMELL STRANGE, SO CONSUMER REMOVED THE PRODUCT AND ADHESIVE WAS STUCK TO THE WOUND AND IT DID NOT COME OFF. CONSUMER REPLACED THE REPORTED PRODUCT WITH UNSPECIFIED LARGE BAND-AID HYDROSEAL BANDAGES AND THE WOUND STARTED TO SMELL STRANGE. CONSUMER WENT TO THE HOSPITAL ON (B)(6) 2024 AND THE ADHESIVE WAS REMOVED WITH TWEEZERS. CONSUMER WAS TOLD AT THE HOSPITAL THAT THERE WOULD BE NO PROBLEM IF CONSUMER PUT REGULAR BAND-AID HYDROSEAL BANDAGES AND UNSPECIFIED LARGE BAND-AID HYDROSEAL BANDAGES. THE CONSUMER BROUGHT THESE NEW BANDAGES TO THE HOSPITAL AND THEY WERE APPLIED TO THE WOUND. THERE IS NO ADDITIONAL INFORMATION WITH REGARDS TO OUTCOME FOR THIS CONSUMER. THIS MEDWATCH IS FOR REGULAR BAND-AID HYDROSEAL BANDAGE, LOT NUMBER IS UNKNOWN. TWO MED WATCHES (2214133-2024-00036) ARE BEING SUBMITTED AS CONSUMER REPORTED USE OF TWO DIFFERENT BOXES WITH TWO DIFFERENT SIZES OF BAND-AIDS WITH THE SAME EVENT DESCRIPTION. SEE MEDWATCH . 2214133-2024-00036. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 26567 | BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES | DRESSING, WOUND, OCCLUSIVE | NAD | JOHNSON & JOHNSON CONSUMER INC | 4901730021906 | N/A | 4901730021906 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |