MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-30 for BAB PLASTIC BANDAGES 381370056355 manufactured by Johnson And Johnson Consumer Inc..
[188327464]
Device was used for treatment, not diagnosis. (b)(4). Lot number = 0879b, expiration date= na. (b)(4). 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 march 28, 2019. (b)(4). 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
[188327465]
A female consumer reported while using band aid plastic to cover a scratch, the bandage tore off her skin while trying to remove it. The consumer sought medical attention and a physician assistant treated her wound and gave her instructions to continue the treatment. The specific treatment was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8041154-2020-00011 |
| MDR Report Key | 9900169 |
| Report Source | CONSUMER |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2019-03-28 |
| Date Added to Maude | 2020-03-30 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LAURIE RAUCO |
| Manufacturer Street | 199 GRANDVIEW RD |
| Manufacturer City | SKILLMAN NJ 085589418 |
| Manufacturer Country | US |
| Manufacturer Postal | 085589418 |
| Manufacturer Phone | 2152734905 |
| Manufacturer G1 | BRAZIL CONSUMER |
| Manufacturer Street | RODOVIA PRESIDENTE DUTRA KM 15 |
| Manufacturer City | S |
| Manufacturer Country | BR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BAB PLASTIC BANDAGES |
| Generic Name | TAPE AND BANDAGE, ADHESIVE |
| Product Code | KGX |
| Date Received | 2020-03-30 |
| Model Number | 381370056355 |
| Lot Number | 0879B |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON AND JOHNSON CONSUMER INC. |
| Manufacturer Address | 199 GRANDVIEW ROAD SKILLMAN NJ 088589418 US 088589418 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |