FDA Adverse Event
Death
Summary report: N
AMS MONARC+ SUBFASCIAL HAMMOCK
MDR report key: 5091521
·
Received September 21, 2015
Report
- Report Number
- 2183959-2014-63118
- Event Type
- Death
- Date Received
- September 21, 2015
- Date of Event
- February 1, 2012
- Report Date
- September 8, 2014
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- OTN
- PMA / PMN Number
- K051530
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THIS WAS INITIALLY REPORTED ON THE SUMMARY REPORT DATED (B)(6) 2014 UNDER EXEMPTION (B)(4). LAWYER-FILED REPORT.
Description of Event or Problem · 1
IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF EXPERIENCED MIXED URINARY INCONTINENCE, VAGINAL VAULT PROLAPSE, RECURRENT MID URETHRAL DESCENT AND INCOMPETENCE OF PUBOCERVICAL TISSUE. THE DEVICE REMAINS IMPLANTED. FURTHERMORE, IT WAS REPORTED THAT THE PLAINTIFF DIED. NO CAUSE OF DEATH WAS REPORTED. RELATED TO MANUFACTURER REPORT #: 2183959-2014-63075; RELATED TO MANUFACTURER REPORT #: 2183959-2014-63794; RELATED TO MANUFACTURER REPORT #: 2183959-2014-63767; RELATED TO MANUFACTURER REPORT #: 2183959-2014-63766.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 621637 | AMS MONARC+ SUBFASCIAL HAMMOCK | MESH, SURGICAL, POLYMERIC | OTN | AMERICAN MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Death | ELEVATE ANTERIOR| MINIARC SLING| PERIGEE| SPARC| PERIGEE |