FDA Adverse Event
Injury
Summary report: N
GYNECARE GYNEMESH* PS
MDR report key: 3178273
·
Received June 19, 2013
Report
- Report Number
- 2210968-2013-10581
- Event Type
- Injury
- Date Received
- June 19, 2013
- Report Date
- June 11, 2013
- Manufacturer
- ETHICON INC.
- Product Code
- OTO
- PMA / PMN Number
- K013718
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.
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 ON (B)(6) 2005 AND MESH AND AMERICAN MEDICAL SYSTEMS, INC. - BIOARC SP SYSTEM WITH INTEXEN LP WERE IMPLANTED. 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 |
|---|---|---|---|---|---|---|---|
| 277633 | GYNECARE GYNEMESH* PS | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC | OTO | ETHICON INC. | UNK | ULP409 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | BIOARC SP SYSTEM INTEXEN LP |