MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-02-05 for OCL UNK manufactured by Medical Device Mfg. & Distribution.
[20242837]
Reporting physician claims that use of "sugar tong splint" caused severe contact dermatitis on his pt. The dermatitis was so severe that it was more like a burn. Physician believes the inner core material is problem, not the foam. Sugar tong splint report obtained while at physician's office on a related complaint follow-up. Physician met briefly w/investigator during a break from seeing pts. He said he could be contacted later for add'l info. Several calls have been made to his office, but he has not returned them. Sample will not be analyzed at this time. The sample will be used during the follow-up at the mfr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4002235 |
| MDR Report Key | 171960 |
| Date Received | 1998-02-05 |
| Date of Report | 1998-02-05 |
| Date Added to Maude | 1998-06-15 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OCL |
| Generic Name | "SUGAR LONG SPLINT" (22" LONG) |
| Product Code | FYH |
| Date Received | 1998-02-05 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 167221 |
| Manufacturer | MEDICAL DEVICE MFG. & DISTRIBUTION |
| Manufacturer Address | 1310 KISTLER DR. INTECH BUSINESS PARK ENDORA KS 66025 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-02-05 |