FDA Adverse Event
Death
Summary report: N
AMS IN-FAST BONE SCREW SYSTEM
MDR report key: 5471209
·
Received March 1, 2016
Report
- Report Number
- 3011770902-2016-00103
- Event Type
- Death
- Date Received
- March 1, 2016
- Date of Event
- July 24, 2006
- Report Date
- June 28, 2013
- Manufacturer
- ASTORA WOMEN'S HEALTH LLC
- Product Code
- HWC
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS WAS INITIALLY REPORTED ON THE SUMMARY REPORT DATED 6/30/2014 UNDER EXEMPTION E2013032
Description of Event or Problem · 0
IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF ALLEGEDLY EXPERIENCED EMOTIONAL DISTRESS AND A PRODUCT PROBLEM. IT WAS ALSO REPORTED THAT THE PLAINTIFF EXPERIENCED DYSURIA, URINARY TRACT INFECTION, DISCOMFORT, CHRONIC BACK PAIN, URGE AND STRESS URINARY INCONTINENCE, OVERACTIVE BLADDER AND INCOMPLETE BLADDER EMPTYING. IT WAS ALSO REPORTED THAT THE PLAINTIFF ALLEGEDLY EXPERIENCED RECURRENCE OF SYMPTOMS. FURTHERMORE, IT WAS REPORTED THAT THE PLAINTIFF DIED. THE CAUSE OF DEATH WAS REPORTED AS DRUG INTOXICATION WITH OXYCODONE, DOXYLAMINE, CARISOPRODOL AND QUETIAPINE. RELATED TO MFR # 3011770902-2016-00102, 3011770902-2016-00104 .
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 128145 | AMS IN-FAST BONE SCREW SYSTEM | SCREW, FIXATION, BONE | HWC | ASTORA WOMEN'S HEALTH LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Death | INFAST SLING| T-SLING WITH CENTRASORB| UNKNOWN SLING| UNKNOWN SLING |