MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-07-29 for OCL SUGAR TONG SPLINT manufactured by M-pact Corp..
[22428]
Pt came to the emergency dept on 7/12/96 and was diagnosed with a distal radius fracture. Splint was applied. On 7/22/96 the pt returned to the ed with a healing partial thickness burn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 35026 |
| MDR Report Key | 35026 |
| Date Received | 1996-07-29 |
| Date of Report | 1996-07-29 |
| Date of Event | 1996-07-22 |
| Date Facility Aware | 1996-07-22 |
| Report Date | 1996-07-29 |
| Date Reported to Mfgr | 1996-07-31 |
| Date Added to Maude | 1996-08-09 |
| 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 | OCL SUGAR TONG SPLINT |
| Generic Name | SUGAR TONG SPLINT |
| Product Code | LGF |
| Date Received | 1996-07-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 36441 |
| Manufacturer | M-PACT CORP. |
| Manufacturer Address | 1040 OCL PKWY EUDORA KS 66025 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-07-29 |