MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-21 for HYPERTHERMIA SENSOR ACCESSORY 1614 manufactured by Vmr Products, L.c..
[6375]
During interstial hyperthermia therapy, one catheter overheated. This caused one catheter to fuse into the skin and caused a third degree burn on the skin at the point of entry. The catheter and the antenna broke off at the neck surface. The patient was admitted to the hospital for a surgical consult. The retained portion was removed in the special procedures department in radiology.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 16102 |
| MDR Report Key | 16102 |
| Date Received | 1994-07-21 |
| Date of Report | 1994-02-15 |
| Date of Event | 1994-02-01 |
| Date Facility Aware | 1994-02-01 |
| Report Date | 1994-02-15 |
| Date Added to Maude | 1994-09-15 |
| 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 |
| Reporter Occupation | PHYSICIST |
| 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 | HYPERTHERMIA SENSOR ACCESSORY |
| Generic Name | INTERSTITIA CATHETERS |
| Product Code | LMZ |
| Date Received | 1994-07-21 |
| Catalog Number | 1614 |
| ID Number | 930401 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 16035 |
| Manufacturer | VMR PRODUCTS, L.C. |
| Manufacturer Address | FRUIT HEIGHTS UT 84037 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1994-07-21 |