MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-05 for PDS PLATE UNKNOWN PRODUCT manufactured by Ethicon Inc..
[141041996]
(b)(4). To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. This medwatch is in response to mw5084278.
Patient Sequence No: 1, Text Type: N, H10
[141041997]
It was reported via mw5084278 by the patient that they underwent an unknown procedure on (b)(6) 2019 and suture device was used. The device was explanted on (b)(6) 2019. The patient reported that their cheek hurt. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-80050 |
| MDR Report Key | 8486871 |
| Report Source | CONSUMER |
| Date Received | 2019-04-05 |
| Date of Report | 2019-03-08 |
| Date of Event | 2019-02-07 |
| Date Mfgr Received | 2019-03-08 |
| Date Added to Maude | 2019-04-05 |
| 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 | DARLENE KYLE |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082182792 |
| Manufacturer G1 | ETHICON INC.-GMBH |
| Manufacturer Street | P.O. BOX 1409 D22841 |
| Manufacturer City | NORDERSTEDT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PDS PLATE UNKNOWN PRODUCT |
| Generic Name | POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE |
| Product Code | NHB |
| Date Received | 2019-04-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-05 |