MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-10-17 for V. MUELLER PVA SURGICAL SPEAR * 23275-500 manufactured by Medsorb Dominicana, S.a..
[17369892]
Patient with corneal scar had a corneal transplant and became infected with staphylococcus aureus. The facility contacted rep when they obtained the recall notice on product 23275-500(05d0915, 05d0916) as they had this product on their shelf and may have used it on this patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680271-2005-00001 |
| MDR Report Key | 642462 |
| Date Received | 2005-10-17 |
| Date Facility Aware | 2005-09-30 |
| Report Date | 2005-10-17 |
| Date Reported to FDA | 2005-09-30 |
| Date Reported to Mfgr | 2005-09-30 |
| Device Manufacturer Date | 2005-04-01 |
| Date Added to Maude | 2005-10-25 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Manufacturer Phone | ** |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | V. MUELLER PVA SURGICAL SPEAR |
| Generic Name | OPHTHALMIC SPONGE |
| Product Code | HOZ |
| Date Received | 2005-10-17 |
| Returned To Mfg | 2005-10-12 |
| Model Number | * |
| Catalog Number | 23275-500 |
| Lot Number | 05D0915 |
| ID Number | * |
| Device Availability | R |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 631996 |
| Manufacturer | MEDSORB DOMINICANA, S.A. |
| Manufacturer Address | ZONA FRANCA INDUSTRIAL SAN PEDRO DE MACORIS DR |
| Baseline Brand Name | V. MUELLER PVA SURGICAL SPEAR |
| Baseline Generic Name | OPHYTHALMIC SPONGE |
| Baseline Model No | * |
| Baseline Catalog No | 23275-500 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-10-17 |