MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-09 for J&J BAND AID BRAND FIRST AID GAUZE PADS 381371161270 manufactured by Johnson & Johnson Consumer Inc.
[141364643]
Device was used for treatment, not diagnosis. Year of birth: (b)(6). Patient ethnicity and race not provided. Udi number: (b)(4). Upc = (b)(4). Expiration date= na. Lot number = 1928a. Concomitant medical products: 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 july 11, 2018. This is 1 of 2 med-watches being submitted as two devices were involved in this event. See medwatch 2214133-2019-00068. 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.
Patient Sequence No: 1, Text Type: N, H10
[141364644]
It was reported by a consumer? S wife that after surgery the consumer used j&j band aid brand first aid gauze pads on his arm. On (b)(6) 2019 the consumer experienced an increase in itching and swelling where the pads were located. He had already had blisters before product use, he saw increased swelling and itching after applying the pads. The consumer sought medical attention from a health care professional (hcp). The event was treated with a prescription anti-itch cream and prescription antibiotic cream. At this time, the patient is still experiencing symptoms. This is 1 of 2 medwatches being submitted as two devices were involved in this event. See medwatch 2214133-2019-00068. The same patient is represented in each medwatch.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2214133-2019-00067 |
| MDR Report Key | 8496538 |
| Report Source | CONSUMER |
| Date Received | 2019-04-09 |
| Date of Report | 2019-03-13 |
| Date of Event | 2019-03-12 |
| Date Mfgr Received | 2019-03-13 |
| Device Manufacturer Date | 2018-07-11 |
| Date Added to Maude | 2019-04-09 |
| 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.18 QIXING RD MAJIADIAN TOWN ZHIJIANG CITY |
| Manufacturer City | HUBEI PROVINCE |
| Manufacturer Country | CH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | J&J BAND AID BRAND FIRST AID GAUZE PADS |
| Generic Name | GAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE |
| Product Code | NAB |
| Date Received | 2019-04-09 |
| Model Number | 381371161270 |
| Lot Number | 1928A |
| 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 | 2019-04-09 |