MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-05-03 for HYDROCOLLATOR NONE manufactured by Hydrocollator Chattanoga Corp..
[133353]
Hydrocollator steam pack to pt's right calf causing 5 blisters to that area. Order from md for hot packs to right calf for treatment of deep vein thrombosis. Hot pack left in place one hour causing blisters to the right calf. Doctor notified and the pt was treated by the facility wound care specialist.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 167280 |
| MDR Report Key | 167280 |
| Date Received | 1998-05-03 |
| Date of Report | 1998-05-01 |
| Date of Event | 1998-04-23 |
| Date Facility Aware | 1998-04-24 |
| Date Reported to FDA | 1998-05-07 |
| Date Added to Maude | 1998-05-14 |
| 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 | HYDROCOLLATOR |
| Generic Name | STEAM HEAT PACKS |
| Product Code | IMA |
| Date Received | 1998-05-03 |
| Model Number | NONE |
| Catalog Number | NONE |
| Lot Number | NONE |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 15 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 162779 |
| Manufacturer | HYDROCOLLATOR CHATTANOGA CORP. |
| Manufacturer Address | * CHATTANOGA TN 37405 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-05-03 |