MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-07-29 for POREX SURGICAL PRODUCTS * #81118 DTM 18MM manufactured by Porex Surgical Inc..
[258744]
Pt had jones tube inserted right eye. Attempted with 18mm medpore wrapped jones tube; tube broke and all pieces recovered. Attempted 20mm. Medpore wrapped jones tube; tube broke all pieces recovered. 3rd attempt with smaller, plain jones tube successful.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 409659 |
| MDR Report Key | 409659 |
| Date Received | 2002-07-29 |
| Date of Report | 2002-07-29 |
| Date of Event | 2002-07-12 |
| Date Facility Aware | 2002-07-25 |
| Report Date | 2002-07-29 |
| Date Reported to FDA | 2002-07-29 |
| Date Reported to Mfgr | 2002-07-29 |
| Date Added to Maude | 2002-08-13 |
| 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 |
| 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 | POREX SURGICAL PRODUCTS |
| Generic Name | MEDPOR SURGICAL IMPLANT |
| Product Code | HNL |
| Date Received | 2002-07-29 |
| Model Number | * |
| Catalog Number | #81118 DTM 18MM |
| Lot Number | 003430502 H |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 398672 |
| Manufacturer | POREX SURGICAL INC. |
| Manufacturer Address | 15 DART ROAD NEWMAN GA 30265 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-07-29 |