MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2020-03-14 for PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT manufactured by Ethicon Inc..
[186522222]
(b)(4). To date the device has not been returned. If the device or further details are received at the later date a supplemental medwatch will be sent.
Patient Sequence No: 1, Text Type: N, H10
[186522223]
It was reported that the patient underwent an elective gynecological procedure on unknown date and the mesh was implanted to address pelvic organ prolapse. The patient experienced pain and incontinence post-op and required further interventions. The patient underwent a partial vaginal excision of mesh in 2016. No further information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-02094 |
| MDR Report Key | 9833020 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2020-03-14 |
| Date of Report | 2020-02-19 |
| Date of Event | 2006-01-01 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-03-14 |
| 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 | 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 SARL-NEUCHATEL |
| Manufacturer Street | PUITS-GODET 20 |
| Manufacturer City | NEUCHATEL |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT |
| Generic Name | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC |
| Product Code | OTP |
| Date Received | 2020-03-14 |
| 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. Congenital Not Applicablenomaly; 2. Required No Informationntervention | 2020-03-14 |