MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2001-05-17 for OCL SPLINT NOT REPORTED manufactured by M-pact Worldwide Mgmt Corp.
[189690]
Post left forearm nondisplaced torus fracture to the distal radial shaft, pt was reported to be splinted with an ocl sugar tong splint. On next examination report in 1996, two healing partial thickness burn areas on the dorsal volar forearm were noted, dorsal as moderate depth, and volar as 2nd degree.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1928508-2001-00001 |
| MDR Report Key | 333831 |
| Report Source | 00 |
| Date Received | 2001-05-17 |
| Date of Report | 2001-04-15 |
| Date of Event | 1996-07-12 |
| Date Mfgr Received | 2001-05-08 |
| Date Added to Maude | 2001-05-23 |
| 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 PARKWAY |
| 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 SPLINT |
| Generic Name | PLASTER SPLINTING |
| Product Code | FYH |
| Date Received | 2001-05-17 |
| Model Number | NOT REPORTED |
| Catalog Number | NOT REPORTED |
| Lot Number | NOT REPORTED |
| 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 | 323195 |
| Manufacturer | M-PACT WORLDWIDE MGMT CORP |
| Manufacturer Address | 1040 OCL PARKWAY EUDORA KS 66025 US |
| Baseline Brand Name | OCL SPLINT |
| Baseline Generic Name | PLASTER SPLINTING |
| Baseline Model No | NOT REPORTED |
| Baseline Catalog No | NOT REPORTED |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2001-05-17 |