MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-07 for MATRESPONDER manufactured by Pyng Medical Corp..
[54665422]
(b)(4). Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[54665427]
The following event description was provided by the initial reporters: "traumatic amputation of leg came into trauma room. First matresponder (tourniquet) used failed. Second matresponder (tourniquet) also failed. The ratchet mechanism let go spontaneously and was unable to be re-tightened. An alternate product was used. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615387-2016-00002 |
| MDR Report Key | 5934766 |
| Date Received | 2016-09-07 |
| Date of Report | 2016-09-07 |
| Date of Event | 2016-05-20 |
| Date Mfgr Received | 2016-08-12 |
| Device Manufacturer Date | 2015-07-01 |
| Date Added to Maude | 2016-09-07 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. TIMOTHY VERSPAGEN |
| Manufacturer Street | 13480 CRESTWOOD PLACE UNIT 210 |
| Manufacturer City | RICHMOND, BRITISH COLUMBIA V6V 2J9 |
| Manufacturer Country | CA |
| Manufacturer Postal | V6V 2J9 |
| Manufacturer Phone | 3037964 |
| Manufacturer G1 | ACCUMED CORP. |
| Manufacturer Street | WAREHOUSE BUILDING 09 NIGUA ZONA FRANCA DE NIGUA |
| Manufacturer City | SAN CRISTOBAL, SAN CRISTOBAL |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MATRESPONDER |
| Generic Name | TOURNIQUET |
| Product Code | GAX |
| Date Received | 2016-09-07 |
| Model Number | MATR |
| Catalog Number | MATR |
| Lot Number | SL122215 |
| Operator | EMERGENCY MEDICAL TECHNICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PYNG MEDICAL CORP. |
| Manufacturer Address | 13480 CRESTWOOD PLACE UNIT 210 RICHMOND, BRITISH COLUMBIA V6V 2J9 CA V6V 2J9 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-09-07 |