FDA Adverse Event
Injury
Summary report: N
PELVILACE® TO TRANS-OBTURATOR BIOURETHRAL SUPPORT SYSTEM WITH HALO NEEDLE
MDR report key: 3315317
·
Received August 23, 2013
Report
- Report Number
- 1018233-2013-06775
- Event Type
- Injury
- Date Received
- August 23, 2013
- Report Date
- December 14, 2016
- Manufacturer
- TISSUE SCIENCE LABORATORIES
- Product Code
- PAG
- PMA / PMN Number
- K042949
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, 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 THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN AND SUFFERING, PERMANENT INJURY, AND WILL LIKELY UNDERGO CORRECTIVE SURGERY.
Description of Event or Problem · 1
PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED BLOOD LOSS, PAIN, STRESS URINARY INCONTINENCE, NONSURGICAL AND ADDITIONAL SURGICAL INTERVENTIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 414802 | PELVILACE® TO TRANS-OBTURATOR BIOURETHRAL SUPPORT SYSTEM WITH HALO NEEDLE | PAG | TISSUE SCIENCE LABORATORIES | NA | CVSA0015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Required Intervention |