MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-08-24 for * ZIM60-7075-103 60-7075-103 manufactured by Sterilmed.
[19227446]
Physician was doing an endoscopic carpal tunnel and the tourniquet failed (deflated). An open carpal tunnel was performed to complete procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2723143 |
| MDR Report Key | 2723143 |
| Date Received | 2012-08-24 |
| Date of Report | 2012-08-24 |
| Date of Event | 2012-08-22 |
| Report Date | 2012-08-24 |
| Date Reported to FDA | 2012-08-24 |
| Date Added to Maude | 2012-08-31 |
| 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 | 3 |
| 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 | * |
| Generic Name | NONPNEUMATIC, TOURNIQUET |
| Product Code | GAX |
| Date Received | 2012-08-24 |
| Returned To Mfg | 2012-08-24 |
| Model Number | ZIM60-7075-103 |
| Catalog Number | 60-7075-103 |
| Lot Number | 1378545 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED |
| Manufacturer Address | 11400 73RD AVENUE NORTH MAPLE GROVE MN 55369 US 55369 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-24 |