MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1998-09-15 for OCL 22" LONG NI manufactured by M-pact Worldwide Management.
[119807]
Physician claims that use of "sugar tong splint" caused severe contact dermatitis on his patient. The dermatitis was so severe that it was more like a burn. Physician believes the inner core material is the problem, not the foam.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1928508-1998-00001 |
| MDR Report Key | 187720 |
| Report Source | 00 |
| Date Received | 1998-09-15 |
| Date of Report | 1998-09-11 |
| Date Added to Maude | 1998-09-21 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OCL 22" LONG |
| Generic Name | SUGAR TONG SPLINT |
| Product Code | FYH |
| Date Received | 1998-09-15 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| 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 | 182446 |
| Manufacturer | M-PACT WORLDWIDE MANAGEMENT |
| Manufacturer Address | 1040 OCL PARKWAY EUDORA KS 66025 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-09-15 |