MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-06 for BSC CLASS II TYPE A BBF3SS RX manufactured by Germfree Laboratories, Inc..
[7081]
Another co replaced motor, blower wheel and capacitor on rptr's device on 6/22/94. They had to rewire the control panel wires which were bare due to cracked and peeling insulation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1002723 |
| MDR Report Key | 14530 |
| Date Received | 1994-07-06 |
| Date of Report | 1994-06-27 |
| Date of Event | 1994-06-22 |
| Date Added to Maude | 1994-07-07 |
| 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 |
| Reporter Occupation | PHARMACIST |
| 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 | BSC CLASS II TYPE A |
| Generic Name | BSC CLASS II TYPE A |
| Product Code | FRF |
| Date Received | 1994-07-06 |
| Model Number | BBF3SS RX |
| ID Number | XXSV 60 HZ 10 AMPS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 14524 |
| Manufacturer | GERMFREE LABORATORIES, INC. |
| Manufacturer Address | MIAMI FL 33166 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-07-06 |