MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2020-03-27 for GYNECARE UNKNOWN PRODUCT manufactured by Ethicon Inc..
[186810480]
(b)(4). To date the device has not been returned yet. If the device or further details are received at the later date a supplemental medwatch will be sent. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. Date and indication of initial surgical procedure for gynecare mesh implant? Please specify gynecare product name, code and/or lot number which was implanted? What were current symptoms following the index surgical procedure? Onset date? Other relevant patient history/concomitant medications? The initial approach for the index surgical procedure? Any concurrent procedure/device implantation? Were there any intra-operative complications? Does? Mesh at vault? Mean mesh eroded? If yes, please specify mesh erosion site/location, symptoms and diagnostic confirmation? When was the mesh erosion first noted by a physician? Describe any medical/surgical intervention for exposure including dates and surgical findings. What is physician? S opinion as to the etiology of or contributing factors to this event (vaginal discharge, and mesh at vault)? What is the patient's current status? The patient demographic info: age, weight, bmi at the time of index procedure?
Patient Sequence No: 1, Text Type: N, H10
[186810481]
It was reported that the patient underwent a sacrocolpopexy procedure on unknown date and the mesh was implanted. It was reported that the patient required pessary management due to treatment failure. The patient complained of offensive vaginal discharge and examined regularly. In december, there was a new finding of mesh at vault which will be discussed at mdt with likely onward referral to mesh center. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-02444 |
| MDR Report Key | 9892376 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-02-17 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-27 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | ETHICON INC.-SAN LORENZO PR |
| Manufacturer Street | 982 ROAD 183 KM 8.3 |
| Manufacturer City | SAN LORENZO PR |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GYNECARE UNKNOWN PRODUCT |
| Generic Name | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC |
| Product Code | OTO |
| Date Received | 2020-03-27 |
| 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 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-27 |