MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-05-03 for MEDPOR SURGICAL IMPLANT P-358-01 * manufactured by Medpor.
[247342]
Medpor coated tear drain shattered on insertion of lacrimal system left eye. All pieces retrieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1024971 |
| MDR Report Key | 393501 |
| Date Received | 2002-05-03 |
| Date of Report | 2002-05-03 |
| Date of Event | 2002-04-26 |
| Date Added to Maude | 2002-05-14 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDPOR SURGICAL IMPLANT |
| Generic Name | MEDPOR COATED TEAR DRAIN 3.5 X 18MM |
| Product Code | HNL |
| Date Received | 2002-05-03 |
| Model Number | P-358-01 |
| Catalog Number | * |
| Lot Number | 012250402H |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 382523 |
| Manufacturer | MEDPOR |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-05-03 |