FDA Adverse Event
Injury
Summary report: N
CONTIGEN BARD COLLAGEN IMPLANT TREATMENT SYRINGE
MDR report key: 4212956
·
Received October 24, 2014
Report
- Report Number
- 1018233-2014-00289
- Event Type
- Injury
- Date Received
- October 24, 2014
- Report Date
- October 2, 2014
- Manufacturer
- C.R. BARD, INC. (COVINGTON)
- Product Code
- LNM
- PMA / PMN Number
- P900030
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE WAS NOT RETURNED. THE LOT NUMBER IS UNK; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED IN THE PT'S MEDICAL RECORDS THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PT HAS EXPERIENCED URINARY STRESS INCONTINENCE AND INTRINSIC SPHINCTER DEFICIENCY WHICH REQUIRED ADDITIONAL SURGICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 678052 | CONTIGEN BARD COLLAGEN IMPLANT TREATMENT SYRINGE | LNM | C.R. BARD, INC. (COVINGTON) | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |