MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 1999-06-18 for CASE IV 5000 manufactured by Wr Medical Electronics.
[125036]
After being given the case iv heat/pain test, the pt experienced a second degree burn (red skin, small ulcer) on the site where the thermal stimulator was attached. Treatment consisted of flammazine daily under a bandage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2118418-1999-00001 |
| MDR Report Key | 228293 |
| Report Source | 01 |
| Date Received | 1999-06-18 |
| Date of Report | 1999-06-15 |
| Date of Event | 1999-04-21 |
| Report Date | 1999-05-15 |
| Date Mfgr Received | 1999-05-15 |
| Date Added to Maude | 1999-06-24 |
| 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 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CASE IV |
| Generic Name | COMPUTER AIDED SENSORY EVALUATOR |
| Product Code | LLN |
| Date Received | 1999-06-18 |
| Returned To Mfg | 1999-05-15 |
| Model Number | IV |
| Catalog Number | 5000 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 221376 |
| Manufacturer | WR MEDICAL ELECTRONICS |
| Manufacturer Address | 123 NORTH 2ND STREET STILLWATER MN 55082 US |
| Baseline Brand Name | CASE IV |
| Baseline Generic Name | NA |
| Baseline Model No | IV |
| Baseline Catalog No | 5000 |
| Baseline ID | NA |
| Baseline Device Family | NEUROPATHY PRODUCT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K910624 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-06-18 |