MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-05-20 for MEDRAD, INC. H5P manufactured by Medrad, Inc..
[17024646]
Patient was receiving an iv carotid dsa when she complained of electric shock. Investigation found unit met all safety parameters ion static mode. We could not duplicate incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 13368 |
| MDR Report Key | 13368 |
| Date Received | 1994-05-20 |
| Date of Report | 1994-03-23 |
| Date of Event | 1994-03-11 |
| Date Facility Aware | 1994-03-11 |
| Report Date | 1994-03-23 |
| Date Reported to Mfgr | 1994-03-24 |
| Date Added to Maude | 1994-05-23 |
| 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 | MEDRAD, INC. |
| Generic Name | INJECTOR |
| Product Code | DQF |
| Date Received | 1994-05-20 |
| Model Number | H5P |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 13366 |
| Manufacturer | MEDRAD, INC. |
| Manufacturer Address | 271 KAPPA DRIVE PITTSBURGH PA 152382817 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 1994-05-20 |