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 2020-03-23 for GYNECARE TVT OBTURATOR 810081 manufactured by Ethicon Inc..
[186525210]
(b)(4). A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria. Attempts are being made to obtain a device for evaluation. 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. Additional information was requested, and the following was obtained: indication for (b)(6) 2012 initial surgical procedure? Yes. Were any concomitant procedures performed? Laparoscopic left salpingo-oophorectomy at time of tvt-o (b)(6) 2012. What medical intervention was given for the pain management? Results? Currently seeing nambour pain service. What was an indication/diagnostic confirmation for complete mesh excision? Chronic pelvic pain. Surgical findings of (b)(6) 2020 mesh excision procedure? No mesh exposure in vagina; no mesh erosion in bladder or urethra. What is physician? S opinion as to the etiology of or contributing factors to this event? Uncertain. What is the patient's current status? Still seeing pain service for management. Was pain and dyspareunia resolved after mesh excision? Has not had follow up yet with our service but is still seeing pain service for pain management. As patient underwent complete excision tvt-o recently on (b)(6) 2020, jjm would like to confirm if there is any product available for collection to be sent back for evaluation? All product is at the hospital lab for processing.
Patient Sequence No: 1, Text Type: N, H10
[186525211]
It was reported that the patient underwent a laparoscopic left salpingo-oophorectomy procedure on (b)(6) 2012 and the mesh was implanted. The patient experienced a lower abdominal pain and dyspareunia occurred 1-2 years following insertion of mesh. The patient underwent a complete excision of mesh on (b)(6) 2020 due to chronic pelvic pain. There were no mesh exposure in vagina and no mesh erosion in bladder or urethra found during mesh excision. Currently, the patient has not had follow up yet with our service but is still seeing pain service for pain management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-02293 |
| MDR Report Key | 9867817 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2020-03-23 |
| Date of Report | 2020-02-25 |
| Date of Event | 2014-01-17 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2011-08-23 |
| Date Added to Maude | 2020-03-23 |
| 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 | GYNECARE TVT OBTURATOR |
| Generic Name | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC |
| Product Code | OTN |
| Date Received | 2020-03-23 |
| Model Number | 810081 |
| Catalog Number | 810081 |
| Lot Number | 3560734 |
| Device Expiration Date | 2012-07-31 |
| 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 | 2020-03-23 |