MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-11-19 for J&J BAND AID BRAND FIRST AID NON STICK PADS 381371161430 manufactured by Johnson & Johnson Consumer Inc.
[127610048]
Device was used for treatment, not diagnosis. Year of birth (b)(6). Patient ethnicity and race was not provided for reporting. Udi #:(b)(4), udi: (b)(4), upc = (b)(4), expiration date= na, lot number = (10)1038a. Device is not expected to be returned for manufacturer review/investigation. Device history records review was completed. No non-conformance reports were generated during production. Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition and product was manufactured per specification. The product was manufactured on april 3, 2018. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[127610049]
A (b)(6) female consumer called to report that she had to go to urgent care to remove a johnson and johnson band-aid brand first aid product non-stick pad. The consumer stated to only have used the one bandage for the wound on her right leg. Consumer indicates that on (b)(6) 2018 she had tried taking the pad off the wound, but was unsuccessful. For treatment the consumer tried soaking the pad in the bathtub, but was unable to remove the pad. The consumer reports that on (b)(6) 2018 she went to urgent care where the pad was removed by a doctor and she was discharged the same day. The consumer has also indicated that skin came off when the bandage was removed and that once the doctor had removed the pad it was replaced with one of the urgent care? S bandages. The consumer indicated that she used an antibiotic ointment when applying the initial bandage to the wound. The consumer reports that she still feels soreness in the affected area that the adhesive was removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2214133-2018-00053 |
| MDR Report Key | 8085452 |
| Report Source | CONSUMER |
| Date Received | 2018-11-19 |
| Date of Report | 2018-10-24 |
| Date of Event | 2018-10-20 |
| Date Mfgr Received | 2018-10-24 |
| Device Manufacturer Date | 2018-04-03 |
| Date Added to Maude | 2018-11-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LINDA PLEWS |
| Manufacturer Street | 199 GRANDVIEW RD |
| Manufacturer City | SKILLMAN NJ 085589418 |
| Manufacturer Country | US |
| Manufacturer Postal | 085589418 |
| Manufacturer Phone | 2152737120 |
| Manufacturer G1 | ALLMED MEDICAL PRODUCTS CO. LTD |
| Manufacturer Street | NO.180 GONG YUAN ROAD, MAJIADIAN TOWN, |
| Manufacturer City | ZHIJIANG CITY, HUBEI 443200 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 443200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | J&J BAND AID BRAND FIRST AID NON STICK PADS |
| Generic Name | GAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE |
| Product Code | NAB |
| Date Received | 2018-11-19 |
| Model Number | 381371161430 |
| Lot Number | 1038A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON CONSUMER INC |
| Manufacturer Address | 199 GRANDVIEW RD SKILLMAN NJ 085589418 US 085589418 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-11-19 |