MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-27 for TVT EXACT RETROPUBIC SYSTEM TVTRL manufactured by Ethicon Inc..
[186811868]
(b)(4). A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified. 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: it is not possible to obtain further details or no additional information is available. The patient demographic info: age, weight, bmi at the time of index procedure? Other relevant patient comorbidities/concomitant medications? Please confirm if mesh product tvtrl with lot number 3933009 was implanted in (b)(6) 2019? The initial approach for the index surgical procedure? Any concurrent procedure/device implantation? Were there any intra-operative complications? When was the mesh exposure first noted by a physician? Mesh exposure site/location and diagnostic confirmation? What is physician? S opinion as to the etiology of or contributing factors to this event? What is the patient's current status?
Patient Sequence No: 1, Text Type: N, H10
[186811869]
It was reported that the patient underwent a sling procedure on (b)(6) 2019 and the mesh was implanted. On (b)(6) 2020 the patient was seeing by doctor due to painful intercourse and at the examination, the relatively distal a 1 cm diameter mesh erosion with the sling mesh in the bottom was observed. Overstin gel was applied by the doctor and the patient was instructed to lubricate daily until the surgery on (b)(6) 2020. At the surgery, an edge of the mucosa throughout the defect circumference was removed and closed the defect. No further information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-02420 |
| MDR Report Key | 9888562 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-02-07 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2018-10-01 |
| 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 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 | TVT EXACT RETROPUBIC SYSTEM |
| Generic Name | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC |
| Product Code | OTN |
| Date Received | 2020-03-27 |
| Model Number | TVTRL |
| Catalog Number | TVTRL |
| Lot Number | 3933009 |
| Device Expiration Date | 2019-09-30 |
| 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 |