FDA Adverse Event
Malfunction
Summary report: N
LATEX-FREE O-RINGS 100PK
MDR report key: 2558245
·
Received April 26, 2012
Report
- Report Number
- 2523190-2012-00043
- Event Type
- Malfunction
- Date Received
- April 26, 2012
- Report Date
- April 26, 2012
- Manufacturer
- INTEGRA YORK, PA INC.
- Product Code
- EXX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.
Description of Event or Problem · 1
NON-LATEX O-RING PRODUCT IS TOO FLEXIBLE. IT LOOSENS AND FALLS OFF HEMORRHOID ALLOWING BLEEDING. NO HEMORRHAGE EVENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LATEX-FREE O-RINGS 100PK | M17-RECTAL | EXX | INTEGRA YORK, PA INC. | 31124638 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |