MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1999-11-17 for OCL NR manufactured by M-pact World Wide Management.
[19159184]
Cellulitis or burn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1928508-1999-00002 |
| MDR Report Key | 250756 |
| Report Source | 00 |
| Date Received | 1999-11-17 |
| Date of Report | 1999-11-16 |
| Date of Event | 1997-06-22 |
| Date Mfgr Received | 1999-06-18 |
| Date Added to Maude | 1999-11-23 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | AL BOEDEKER |
| Manufacturer Street | 1040 OCL PKWY |
| Manufacturer City | EUDORA KS 66025 |
| Manufacturer Country | US |
| Manufacturer Postal | 66025 |
| Manufacturer Phone | 7855422920 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OCL |
| Generic Name | SPLINT |
| Product Code | FYH |
| Date Received | 1999-11-17 |
| Model Number | NR |
| Catalog Number | NR |
| Lot Number | NR |
| ID Number | * |
| 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 | 242937 |
| Manufacturer | M-PACT WORLD WIDE MANAGEMENT |
| Manufacturer Address | 1040 OCL PKWY EUDORA KS 66025 US |
| Baseline Brand Name | OCL |
| Baseline Generic Name | SPLINT |
| Baseline Model No | NR |
| Baseline Catalog No | NR |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1999-11-17 |