FDA Adverse Event
Injury
Summary report: N
ALIGN TO URETHRAL SUPPORT SYSTEM
MDR report key: 3351737
·
Received September 10, 2013
Report
- Report Number
- 1018233-2013-07284
- Event Type
- Injury
- Date Received
- September 10, 2013
- Report Date
- August 22, 2016
- Manufacturer
- BARD SHANNON LIMITED
- Product Code
- OTN
- PMA / PMN Number
- K070073
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE WAS NOT RETURNED. THE FINISHED PRODUCT MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED FOR GENERAL DISTRIBUTION. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
(B)(4). IT WAS REPORTED BY THE PT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PT HAS EXPERIENCED PAIN, DISABILITY AND IMPAIRMENT.
Description of Event or Problem · 1
PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED VAGINAL BULGE/PROLAPSE, FECAL SEEPAGE, ANTERIOR WALL DESCENT/CYSTOCELE, LEFT LEG PAIN, BLOOD LOSS AND NONSURGICAL AND ADDITIONAL SURGICAL INTERVENTIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 454405 | ALIGN TO URETHRAL SUPPORT SYSTEM | OTN | BARD SHANNON LIMITED | NA | HUSB0013 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention | AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, ANTERIOR: | AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, POSTERIOR: | REF# 486200, LOT HUSB1067| REF#: 486100, LOT# CVSC0011| AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, POSTERIOR:| REF# 486200, LOT HUSB1067| REF#: 486100, LOT# CVSC0011 |