MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-05-31 for J&J BAND AID BRAND FIRST AID HURT FREE NON STICK PADS 381371161423 manufactured by Johnson & Johnson Consumer Inc..
[146711030]
Device was used for treatment, not diagnosis. Patient information: year of birth, weight, patient ethnicity and race were not provided. Udi number: (b)(4). Upc = (b)(4). Lot number = 3428a. Device available for evaluation: device is not expected to be returned for manufacturer review/investigation. Device evaluated by mfr, manufacture date: device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. A review of the device history records has been requested. 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
[146711031]
A female consumer stated she used j&j (b)(6) brand first aid hurt free non stick pad and that the product was sticking to the wound on the bottom of her foot and it was painful. The consumer stated she soaked her foot for a half hour to try to remove the product. Consumer stated she sought medical attention from her health care provider (hcp) and her hcp prescribed treatment for the event. Consumer stated the hcp prescribed an unknown antibiotic and unknown ointment. The symptoms have resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2214133-2019-00079 |
| MDR Report Key | 8660145 |
| Report Source | CONSUMER |
| Date Received | 2019-05-31 |
| Date of Report | 2019-06-03 |
| Date Mfgr Received | 2019-06-03 |
| Device Manufacturer Date | 2018-12-21 |
| Date Added to Maude | 2019-05-31 |
| 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 |
| Manufacturer Street | NO. 18 QIXING ROAD MAJIADIAN TOWN |
| Manufacturer City | ZHIJIANG CITY, HUBEI PROVINCE 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 HURT FREE NON STICK PADS |
| Generic Name | GAUZE/SPONGE,NONRESORBABLE FOR EXTERNAL USE |
| Product Code | NAB |
| Date Received | 2019-05-31 |
| Model Number | 381371161423 |
| Lot Number | 3428A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON CONSUMER INC. |
| Manufacturer Address | 199 GRANDVIEW ROAD SKILLMAN NJ 085589418 US 085589418 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-31 |