MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-07-10 for TOURNIQUET MACHINE ATS-1500 604000-001 manufactured by Zimmer.
[21715388]
Tourniquet was properly placed on pt's right arm and the connectors were tightened. Medication was injected. The tourniquet allowed blood flow into operative site. The tourniquet had to be removed and a new one applied. The pt required 7. 5 cc 2% xylocaine add'l medication, and the or time was extended about 20 minutes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 24224 |
| MDR Report Key | 24224 |
| Date Received | 1995-07-10 |
| Date of Report | 1995-01-09 |
| Date of Event | 1995-01-06 |
| Date Facility Aware | 1995-01-09 |
| Report Date | 1995-01-09 |
| Date Reported to Mfgr | 1995-01-09 |
| Date Added to Maude | 1995-08-10 |
| 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 | UNKNOWN |
| 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 | TOURNIQUET MACHINE |
| Generic Name | TOURNIQUET MACHINE |
| Product Code | DRP |
| Date Received | 1995-07-10 |
| Model Number | ATS-1500 |
| Catalog Number | 604000-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 12 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 24590 |
| Manufacturer | ZIMMER |
| Manufacturer Address | WARSAW IN 465810708 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-07-10 |