MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-09-13 for J&J BAND AID BRAND FIRST AID NON STICK PADS 381371161430 manufactured by Johnson & Johnson Consumer Inc.
[120118998]
Device was used for treatment, not diagnosis. Patient ethnicity and race was not provided for reporting. (b)(4). Expiration date= na. Lot number = (10)0668a. 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. 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
[120118999]
A wife called in to report that her (b)(6) male husband got a burn from the non stick pads. She stated that he was using the pad to help cover a wound on the top of his foot. She stated that he used 1 pad on (b)(6) 2018 and only had it on for about 2 hours and the last time he used it was on (b)(6) 2018. He is still experiencing the symptoms because his foot is still a little red. He did go to the an urgent care doctor and she prescribed him an antibiotic cream to help treat it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2214133-2018-00045 |
| MDR Report Key | 7872350 |
| Report Source | CONSUMER |
| Date Received | 2018-09-13 |
| Date of Report | 2018-09-17 |
| Date of Event | 2018-08-24 |
| Date Mfgr Received | 2018-09-17 |
| Device Manufacturer Date | 2018-03-06 |
| Date Added to Maude | 2018-09-13 |
| 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. 76 YOUYI ROAD, |
| 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 | 2018-09-13 |
| Model Number | 381371161430 |
| Lot Number | 0668A |
| 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 RD SKILLMAN NJ 085589418 US 085589418 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-09-13 |