MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2015-08-31 for MATRESPONDER TOURNIQUET manufactured by Pyng Medical Corp..
[25528240]
Reference pyng (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[25528241]
An (b)(6) ambulance paramedic team responding to a severed leg emergency could not get the mat responder tourniquet to tighten. When they tried to tighten it by winding the tension key, the tourniquet was not tightening. They also found that they could only wind it? Turn or not at all. From the information that was received to date, they tried 3 different matr's and none worked. Paramedics used a belt for a tourniquet to obtain occlusion. Subsequently, an educator also with nsw ambulance described a similar experience when teaching the tourniquet to paramedics. She was unable to tighten the unit. She put it aside and obtained another unit. This winding key was only able to be turned a couple of times before reaching the end. The 3rd unit that she used was in the expected "ready" position (i. E. , all the way out) and could be used correctly. Following her training session she investigated both "faulty" units and found that they were already wound in. During her examination she found that she could fully release (i. E. , reset) and reuse each unit. She then examined the remaining unopened unit while still in its packaging and upon feeling through the package she discovered that they were all at different points in the winding cycle. As a result nsw ambulance sent an advisory to their field to ensure the tourniquets were in the proper configuration and, if not, to reset them. All units were from lot number sl115802. One of the opened units from the educators training session and the 2 additional stock units known to be in differing states of readiness were returned to pyng. Pyng's investigation of the returned units revealed all of returned units were in different states of winding (i. E. , not completely in their "ready" position). The opened returned unit was approximately 20% wound but it is unlikely this is the original state out of the package, the second unit (packaged) was in a completely wound state and the third unit (packaged) was wound about half the distance.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009615387-2015-00004 |
| MDR Report Key | 5043174 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2015-08-31 |
| Date of Report | 2015-08-27 |
| Date of Event | 2015-03-01 |
| Date Mfgr Received | 2015-07-28 |
| Device Manufacturer Date | 2014-07-01 |
| Date Added to Maude | 2015-08-31 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PAUL CRAMER |
| Manufacturer Street | 210-13480 CRESTWOOD PLACE |
| Manufacturer City | RICHMOND, BRITISH COLUMBIA V6V 2J9 |
| Manufacturer Country | CA |
| Manufacturer Postal | V6V 2J9 |
| Manufacturer Phone | 3037964 |
| Manufacturer G1 | ACCUMED CORP. |
| Manufacturer Street | NIGUA FREE ZONE NIGUA |
| Manufacturer City | SAN CRISTOBAL, |
| Manufacturer Country | DR |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MATRESPONDER TOURNIQUET |
| Generic Name | MATRESPONDER |
| Product Code | GAX |
| Date Received | 2015-08-31 |
| Model Number | MATR |
| Catalog Number | MATR |
| Lot Number | SL115802 |
| Operator | PARAMEDIC |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PYNG MEDICAL CORP. |
| Manufacturer Address | 210-13480 CRESTWOOD PLACE RICHMOND, BRITISH COLUMBIA V6V 2J9 CA V6V 2J9 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-08-31 |