FDA Adverse Event
Injury
Summary report: N
UNKNOWN MESH PRODUCT (EWHU)
MDR report key: 3122632
·
Received May 21, 2013
Report
- Report Number
- 2210968-2013-05742
- Event Type
- Injury
- Date Received
- May 21, 2013
- Report Date
- May 2, 2013
- Manufacturer
- ETHICON, INC.
- Product Code
- FTL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem · 1
IT WAS REPORTED BY THE PATIENT THAT SHE UNDERWENT A GYNECOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND TRANSVAGINAL MESH WAS IMPLANTED. THE PATIENT EXPERIENCES SEVERE PAIN AND HAS ERODING MESH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 224362 | UNKNOWN MESH PRODUCT (EWHU) | MESH, SURGICAL | FTL | ETHICON, INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |