FDA Adverse Event
Injury
Summary report: N
GYNECARE GYNEMESH* PS
MDR report key: 3142640
·
Received June 3, 2013
Report
- Report Number
- 2210968-2013-06397
- Event Type
- Injury
- Date Received
- June 3, 2013
- Report Date
- May 14, 2013
- Manufacturer
- ETHICON, INC.
- Product Code
- OTP
- PMA / PMN Number
- K071512
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- ATTORNEY
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). 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 THAT THE PATIENT UNDERWENT A GYNCOLOGICAL PROCEDURE TO TREAT PELVIC ORGAN PROLAPSE ON (B)(6) 2010 AND A MESH WAS IMPLANTED. THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, FORMATION OF SCAR TISSUE, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO STRUCTURES AND TISSUES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 244872 | GYNECARE GYNEMESH* PS | MESH, SURGICAL, POLYMERIC | OTP | ETHICON, INC. | NA | 3132584 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |