FDA Adverse Event
Injury
Summary report: N
TENSION FREE VAGINAL TAPE
MDR report key: 2880302
·
Received December 19, 2012
Report
- Report Number
- 2210968-2012-08387
- Event Type
- Injury
- Date Received
- December 19, 2012
- Report Date
- November 26, 2012
- Manufacturer
- ETHICON, INC.
- Product Code
- FTL
- PMA / PMN Number
- K100485
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CONCLUSION: THE DEVICE INFORMATION FOR USE STATES, ¿REMOVE THE IMPLANT SHEATHS BY GENTLY PULLING UP ON THE CLAMPS, AWAY FROM THE ABDOMEN ONE AT A TIME."
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE TO TREAT INCONTINENCE ON (B)(6) 2012 AND A SLING WAS IMPLANTED. DURING THE PROCEDURE, THE SURGEON FORGOT TO REMOVE THE SLING SHEET BEFORE HE CUT OFF THE SURPLUS MATERIAL AFTER THE ADJUSTMENT. THE SURGEON ENLARGED HIS ORIGINAL INCISIONS AND WAS ABLE TO REMOVE THE ENTIRE SLING BUT NOT THE ENTIRE SHEATH. A SECOND SURGERY WAS PERFORMED IN (B)(6) 2012 WHERE THE ORIGINAL SHEATH WAS REMOVED AND ANOTHER LIKE DEVICE WAS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TENSION FREE VAGINAL TAPE | MESH, SURGICAL, POLYMERIC | FTL | ETHICON, INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |