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..
[186697356]
(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. 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. Please confirm if mesh product tvtrl with lot number 3931358 was implanted in (b)(6) 2018? Were there any intra-operative complications during (b)(6) 2018 initial surgery? Other relevant patient comorbidities/concomitant medications? Mesh exposure site/location and diagnostic confirmation? Please clarify? Contact hemorrhage? And the volume of bleeding? How the bleeding was treated? Results? Were cultures performed? Results? What is physician? S opinion as to the etiology of or contributing factors to these events (hemorrhage and mesh erosion)? 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
[186697357]
It was reported that the patient underwent a sling procedure on (b)(6) 2018 and the mesh was implanted due to urinary stress incontinence. On (b)(6) 2020 the patient was seeing by doctor due to mesh erosion suspicion. The patient presented contact hemorrhage and foreign body sensation in vagina. At the examination, mesh exposure was found just below meatus urethra with irritation of the surrounding tissue. On (b)(6) 2020 the exposed mesh sling part was removed and sent for cultivation for actinomyces. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-02421 |
| MDR Report Key | 9888911 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-02-10 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2018-01-30 |
| 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 | 3931358 |
| Device Expiration Date | 2018-12-31 |
| 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 | 2020-03-27 |