MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-04-24 for UNKNOWN MISCELLANEOUS DISTRIBUTED PR * 0000018 manufactured by *.
[79613]
Facility alleges transducer exploded, spraying blood in 2 pts faces. Signed consent for hiv testing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243621-1997-06638 |
| MDR Report Key | 105826 |
| Date Received | 1996-04-24 |
| Date of Report | 1996-02-06 |
| Date of Event | 1993-04-08 |
| Date Added to Maude | 1997-07-18 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | UNKNOWN MISCELLANEOUS DISTRIBUTED PR |
| Generic Name | * |
| Product Code | FIB |
| Date Received | 1996-04-24 |
| Model Number | * |
| Catalog Number | 0000018 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 104054 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-04-24 |