MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-10-08 for MECHANICAL ADVANTAGE TOURNIQUET (MAT) MAT01 NA manufactured by Pyng Medical Corp..
[5212580]
Mechanical advantage tourniquet (mat) was applied to a patient with stab wounds to his arm. The mat was reported by the user as being effectively applied, but after approx 5 minutes, the tourniquet broke or ceased to function as the user expected and an alternative tourniquet was used by the paramedic (cravat and pen) to prevent further blood loss.
Patient Sequence No: 1, Text Type: D, B5
[12739875]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615387-2014-00001 |
| MDR Report Key | 4330093 |
| Report Source | 05 |
| Date Received | 2014-10-08 |
| Date of Report | 2014-10-07 |
| Date of Event | 2014-09-07 |
| Date Mfgr Received | 2014-09-11 |
| Device Manufacturer Date | 2008-12-01 |
| Date Added to Maude | 2014-12-23 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHELE TYLER |
| Manufacturer Street | 210-13480 CRESTWOOD PL |
| Manufacturer City | RICHMOND, B.C. V6V 2J9 |
| Manufacturer Country | CA |
| Manufacturer Postal | V6V 2J9 |
| Manufacturer Phone | 003497964 |
| Manufacturer G1 | RISON MANUFACTURING LTD. |
| Manufacturer City | NINGBO, ZHEJIANG |
| Manufacturer Country | CH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MECHANICAL ADVANTAGE TOURNIQUET (MAT) |
| Generic Name | MAT |
| Product Code | GAX |
| Date Received | 2014-10-08 |
| Model Number | MAT01 |
| Catalog Number | NA |
| Lot Number | 848 |
| Device Expiration Date | 2018-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PYNG MEDICAL CORP. |
| Manufacturer Address | 210-13480 CRESTWOOD PL RICHMOND, B.C. V6V2J9 CA V6V 2J9 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-10-08 |