FDA Adverse Event
Injury
Summary report: N
UNKNOWN MESH PRODUCT (EWHU)
MDR report key: 3140596
·
Received May 31, 2013
Report
- Report Number
- 2210968-2013-06328
- Event Type
- Injury
- Date Received
- May 31, 2013
- Report Date
- May 14, 2013
- Manufacturer
- ETHICON, INC.
- Product Code
- FTL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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 THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE TO TREAT PELVIC ORGAN PROLAPSED ON (B)(6) 2007 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, FORMATION OF SCAR TISSUE, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 240921 | UNKNOWN MESH PRODUCT (EWHU) | MESH, SURGICAL | FTL | ETHICON, INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |