FDA Adverse Event
Injury
Summary report: N
TENSION FREE VAGINAL TAPE
MDR report key: 3090326
·
Received May 2, 2013
Report
- Report Number
- 2210968-2013-04880
- Event Type
- Injury
- Date Received
- May 2, 2013
- Report Date
- April 9, 2013
- Manufacturer
- ETHICON, INC.
- Product Code
- OTN
- PMA / PMN Number
- K033568
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
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.IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE TO TREAT STRESS URINARY INCONTINENCE ON (B)(6) 2010 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCE 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 |
|---|---|---|---|---|---|---|---|
| 191141 | TENSION FREE VAGINAL TAPE | MESH, SURGICAL, POLYMERIC | OTN | ETHICON, INC. | NA | 3413120 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |