MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08,distributor,health prof report with the FDA on 2015-06-11 for MATRESPONDER TOURNIQUET manufactured by Pyng Medical Corporation.
[17212043]
Per complainant, the tourniquet ripped apart prior to torquing and a paramedic created a tourniquet which was used to stop bleeding. The only other information obtained was that the patient was unstable at the time of the incident and is now deceased. No further information has been obtained from the complainant at the time of this report filing. Pyng medical was made aware of this event on (b)(4) 2015.
Patient Sequence No: 1, Text Type: D, B5
[17443230]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[33994078]
Insufficient information provided to determine cause of complaint. However this lot of product is being recalled for inspection. See recall notice for mfr report number 9615387-2015-00004.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0009615387-2015-00001 |
| MDR Report Key | 4838796 |
| Report Source | 05,08,DISTRIBUTOR,HEALTH PROF |
| Date Received | 2015-06-11 |
| Date of Report | 2015-09-01 |
| Date of Event | 2015-05-10 |
| Date Mfgr Received | 2015-05-14 |
| Device Manufacturer Date | 2014-07-01 |
| Date Added to Maude | 2015-07-09 |
| 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 | SERVICE PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PAUL CRAMER |
| Manufacturer Street | 210-13480 CRESTWOOD PLACE |
| Manufacturer City | RICHMOND, BRITISH COLUMBIA V6V2J9 |
| Manufacturer Country | CA |
| Manufacturer Postal | V6V2J9 |
| Manufacturer Phone | 3037964 |
| Manufacturer G1 | ACCUMED CORP. |
| Manufacturer Street | NIGUA FREE ZONE NIGUA |
| Manufacturer City | SAN CRISTOBAL, V6V2J9 |
| Manufacturer Country | DR |
| Manufacturer Postal Code | V6V2J9 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MATRESPONDER TOURNIQUET |
| Generic Name | MATRESPONDER |
| Product Code | GAX |
| Date Received | 2015-06-11 |
| Returned To Mfg | 2015-05-28 |
| Model Number | MATR |
| Catalog Number | MATR |
| Lot Number | SL115802 |
| Operator | PARAMEDIC |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PYNG MEDICAL CORPORATION |
| Manufacturer Address | 210-13480 CRESTWOOD PLACE RICHMOND, BRITISH COLUMBIA V6V2J9 CA V6V2J9 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-06-11 |