FDA Adverse Event
Injury
Summary report: N
UNKNOWN MESH PRODUCT (EWHU)
MDR report key: 1900220
·
Received November 10, 2010
Report
- Report Number
- 2210968-2010-01493
- Event Type
- Injury
- Date Received
- November 10, 2010
- Report Date
- October 25, 2010
- Manufacturer
- ETHICON, INC.
- Product Code
- FTL
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
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. ADDITIONAL INFORMATION: THERE ARE TWO POSSIBLE DEVICES INVOLVED IN THE EVENT AS FOLLOWS: PROLIFT PELVIC FLOOR REPAIR, TENSION FREE VAGINAL TAPE / OBTURATOR.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO TREAT STRESS URINARY INCONTINENCE ON (B)(6) 2009, AND AN UNSPECIFIED PRODUCT WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. 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 | UNKNOWN MESH PRODUCT (EWHU) | MESH, SURGICAL | FTL | ETHICON, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |