MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-07 for DISP. 30X4, 1BLA, 2PRT, QUICK CONNECT 5921030235 manufactured by Stryker Instruments-kalamazoo.
[173975048]
The user facility reported that the tourniquet cuff had holes and was leaking during a procedure. There were no reported adverse consequences; there were no procedure delays; there was no medical intervention required. The procedure was completed successfully with a different tourniquet cuff.
Patient Sequence No: 1, Text Type: D, B5
[188145708]
Discarded
Patient Sequence No: 1, Text Type: N, H10
[188145709]
The user facility reported that the tourniquet cuff had holes and was leaking during a procedure. There were no reported adverse consequences; there were no procedure delays; there was no medical intervention required. The procedure was completed successfully with a different tourniquet cuff.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2020-00028 |
| MDR Report Key | 9559295 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-07 |
| Date of Report | 2020-04-03 |
| Date of Event | 2019-12-23 |
| Date Mfgr Received | 2020-04-02 |
| Date Added to Maude | 2020-01-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ZACH BAKER |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | STRYKER INSTRUMENTS-PUERTO RICO |
| Manufacturer Street | LAS PALMAS INDUSTRIAL PARK HIGHWAY #3, KM 130.2 |
| Manufacturer City | ARROYO MI 00615 |
| Manufacturer Country | PR |
| Manufacturer Postal Code | 00615 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISP. 30X4, 1BLA, 2PRT, QUICK CONNECT |
| Generic Name | TOURNIQUET, PNEUMATIC |
| Product Code | KCY |
| Date Received | 2020-01-07 |
| Catalog Number | 5921030235 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Address | 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-07 |