FDA Adverse Event
Injury
Summary report: N
GYNECARE GYNEMESH* PS
MDR report key: 2850653
·
Received November 29, 2012
Report
- Report Number
- 2210968-2012-07575
- Event Type
- Injury
- Date Received
- November 29, 2012
- Report Date
- November 10, 2012
- Manufacturer
- ETHICON, INC.
- Product Code
- FTL
- PMA / PMN Number
- K013718
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- ATTORNEY
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. (B)(4).
Additional Manufacturer Narrative · 1
LAWYER-FILED REPORT (B)(6). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT PELVIC ORGAN PROLAPSE (VAGINAL VAULT AND CYSTOCELE) AND STRESS URINARY INCONTINENCE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS USED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GYNECARE GYNEMESH* PS | MESH, SURGICAL, POLYMERIC | FTL | ETHICON, INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |