MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-07-17 for DRAIN 44410 manufactured by Pudenz-schulte Medical, Corp..
[17189]
On 5/27, drain fractured while physician was attempting to remove. On 5/27, to or - unable to retrieve broken piece. On 5/29, to or - successful removal of drain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 24184 |
| MDR Report Key | 24184 |
| Date Received | 1995-07-17 |
| Date of Report | 1995-06-27 |
| Date of Event | 1995-05-27 |
| Date Added to Maude | 1995-08-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRAIN |
| Generic Name | DRAIN |
| Product Code | HFL |
| Date Received | 1995-07-17 |
| Catalog Number | 44410 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 24541 |
| Manufacturer | PUDENZ-SCHULTE MEDICAL, CORP. |
| Manufacturer Address | GOLETA CA 93117 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-07-17 |