FDA Adverse Event
Death
Summary report: N
PROLIFT PELVIC FLOOR REPAIR
MDR report key: 1705286
·
Received May 28, 2010
Report
- Report Number
- 2210968-2010-00575
- Event Type
- Death
- Date Received
- May 28, 2010
- Report Date
- May 5, 2010
- Manufacturer
- ETHICON, INC.
- Product Code
- FTL
- PMA / PMN Number
- K013718
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B) (4). (B) (4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT UNDERWENT A PELVIC FLOOR PROLAPSE PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SURGEON INJURED A LARGE VESSEL AND COULD NOT STOP THE BLEEDING. THE HEMORRHAGE STARTED WHILE THE DOCTOR WAS PERFORMING THE FINGER DISSECTION. THE PT RECEIVED TWENTY UNITS OF BLOOD, AND UNFORTUNATELY DIED ON THE OPERATING TABLE. ADD'L INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROLIFT PELVIC FLOOR REPAIR | MESH, SURGICAL, POLYMERIC | FTL | ETHICON, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Death| R |