MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-18 for STAGE WARMER, MICROSCOPIC MP10DM 100447 manufactured by Cryo Resources, Ltd..
[9211]
Operator received shock during operation of unit. Contacted mfr, no returned call.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 14175 |
| MDR Report Key | 14175 |
| Date Received | 1994-03-18 |
| Date of Report | 1994-03-15 |
| Date of Event | 1994-03-01 |
| Date Facility Aware | 1994-03-01 |
| Report Date | 1994-03-15 |
| Date Reported to FDA | 1994-03-09 |
| Date Reported to Mfgr | 1994-03-18 |
| Date Added to Maude | 1994-06-21 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | STAGE WARMER, MICROSCOPIC |
| Generic Name | STAGE WARMER, MICROSCOPIC |
| Product Code | IBL |
| Date Received | 1994-03-18 |
| Model Number | MP10DM |
| Catalog Number | 100447 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 24 MO |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 14171 |
| Manufacturer | CRYO RESOURCES, LTD. |
| Manufacturer Address | NEW YORK NY * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-03-18 |