MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-06-05 for JOHNSON & JOHNSON BAND-AID? BRAND OF FIRST AID PRODUCTS GAUZE PADS 381371161232 manufactured by Allmed Medical Products Co. Ltd.
[110039694]
Device was used for treatment, not diagnosis. Patient id, date of birth and weight were not provided for reporting. Udi number: (b)(4). (b)(4). Expiration date= na. Lot number = ni. 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. Device history records review could not be completed without lot number. 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
[110039695]
The incident involves an anonymous female consumer using j&j band-aid brand first aid gauze pads (2x2). On (b)(6) 2018, the consumer? S mother called to report that her daughter had used the j&j band-aid brand first aid gauze pads within her mouth after wisdom teeth removal. The consumer? S mother reported that a piece of the product broke off and was stuck within the back of her daughter? S throat. The consumer? S mother mentioned her daughter? S physician is aware of event and an appointment was made for the following day. She did not treat the event. It is unknown if the gauze was removed from the consumer? S throat or if the situation has otherwise resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2214133-2018-00010 |
| MDR Report Key | 7568462 |
| Report Source | CONSUMER |
| Date Received | 2018-06-05 |
| Date of Report | 2018-05-08 |
| Date Mfgr Received | 2018-05-08 |
| Date Added to Maude | 2018-06-05 |
| 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 | 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, MAJIADIAN TOWN |
| Manufacturer City | ZHIJIANG CITY, HUBEI 443200 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 443200 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JOHNSON & JOHNSON BAND-AID? BRAND OF FIRST AID PRODUCTS GAUZE PADS |
| Generic Name | GAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE |
| Product Code | NAB |
| Date Received | 2018-06-05 |
| Model Number | 381371161232 |
| ID Number | (01)381371161232 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLMED MEDICAL PRODUCTS CO. LTD |
| Manufacturer Address | NO. 76 YOUYI ROAD, MAJIADIAN TOWN ZHIJIANG CITY, HUBEI 443200 CH 443200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-06-05 |