MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-04-26 for LATEX-FREE O-RINGS 100PK 28-155 manufactured by Integra York, Pa Inc..
[2749151]
Non-latex o-ring product is too flexible. It loosens and falls off hemorrhoid allowing bleeding. No hemorrhage events.
Patient Sequence No: 1, Text Type: D, B5
[9810309]
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2012-00043 |
| MDR Report Key | 2558245 |
| Report Source | 06 |
| Date Received | 2012-04-26 |
| Date of Report | 2012-04-26 |
| Date Mfgr Received | 2012-04-19 |
| Date Added to Maude | 2012-09-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA LEE |
| Manufacturer Street | 315 ENTERPRISE |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LATEX-FREE O-RINGS 100PK |
| Generic Name | M17-RECTAL |
| Product Code | EXX |
| Date Received | 2012-04-26 |
| Catalog Number | 28-155 |
| Lot Number | 31124638 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-04-26 |