MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-11-16 for SOFT CELL 0525 manufactured by M-pact Corp.
[19543372]
Md examined ten pts post operatively and four pts exhibited diffuse lamellar keratitis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2083373-2001-00002 |
| MDR Report Key | 362356 |
| Report Source | 05 |
| Date Received | 2001-11-16 |
| Date of Report | 2001-11-15 |
| Date of Event | 2001-10-19 |
| Date Mfgr Received | 2001-10-19 |
| Device Manufacturer Date | 2001-08-01 |
| Date Added to Maude | 2001-12-03 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 514 S. VERMONT AVE. |
| Manufacturer City | GLENDORA CA 91741 |
| Manufacturer Country | US |
| Manufacturer Postal | 91741 |
| Manufacturer Phone | 6269142891 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOFT CELL |
| Generic Name | PVA FOAM SPONGES |
| Product Code | HOZ |
| Date Received | 2001-11-16 |
| Model Number | 0525 |
| Catalog Number | 0525 |
| Lot Number | 1220C |
| ID Number | NA |
| Device Expiration Date | 2004-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 351501 |
| Manufacturer | M-PACT CORP |
| Manufacturer Address | 1040 OCL PARKWAY EUDORA KS 66025 US |
| Baseline Brand Name | SOFT CELL |
| Baseline Generic Name | PVA FOAM SPEARS |
| Baseline Model No | 0525 |
| Baseline Catalog No | 0525 |
| Baseline ID | NA |
| Baseline Device Family | PVA FOAM SURGICAL SPEARS |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K950241 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-11-16 |