MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-10-14 for J&J BAND AID BRAND FIRST AID FLEXIBLE GAUZE ROLLED 381371161416 manufactured by Johnson & Johnson Consumer Inc.
| Report Number | 2214133-2019-00121 |
| MDR Report Key | 9186145 |
| Report Source | CONSUMER |
| Date Received | 2019-10-14 |
| Date of Report | 2019-09-18 |
| Date Mfgr Received | 2019-09-18 |
| Device Manufacturer Date | 2019-05-22 |
| Date Added to Maude | 2019-10-14 |
| 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 | LAURIE RAUCO |
| Manufacturer Street | 199 GRANDVIEW RD |
| Manufacturer City | SKILLMAN NJ 085589418 |
| Manufacturer Country | US |
| Manufacturer Postal | 085589418 |
| Manufacturer Phone | 2152734905 |
| Manufacturer G1 | ALLMED MEDICAL PRODUCTS CO. LTD |
| Manufacturer Street | NO. 76 YOUYI ROAD ZHIJIANG CITY |
| Manufacturer 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 FLEXIBLE GAUZE ROLLED |
| Generic Name | GAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE |
| Product Code | NAB |
| Date Received | 2019-10-14 |
| Model Number | 381371161416 |
| Lot Number | 1319A |
| 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 | 2019-10-14 |