FDA Adverse Event
Injury
Summary report: N
UNKNOWN MESH PRODUCT (EWHU)
MDR report key: 1914975
·
Received November 30, 2010
Report
- Report Number
- 2210968-2010-01622
- Event Type
- Injury
- Date Received
- November 30, 2010
- Report Date
- November 9, 2010
- Manufacturer
- ETHICON, INC.
- Product Code
- FTM
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NOT APPLICABLE
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THERE ARE TWO POSSIBLE DEVICES INVOLVED IN THE EVENT AS FOLLOWS: PROLIFT PELVIC FLOOR REPAIR. TENSION FREE VAGINAL TAPE/OBTURATOR - PRODUCT CODE 810081.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT UNDERWENT SURGERY FOR THE TREATMENT OF STRESS URINARY INCONTINENCE, CYSTOCELE, AND RECTOCELE ON (B)(6) 2007 AND AN OBTURATOR SLING AND PELVIC FLOOR REPAIR MESH WERE IMPLANTED. THE PT EXPERIENCED PAIN AND EROSION OF HER INTERNAL BODILY TISSUE POST-OPERATIVELY. NO ADDITIONAL INFO WAS PROVIDED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN MESH PRODUCT (EWHU) | MESH, SURGICAL | FTM | ETHICON, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Female | Required Intervention |