MATRESPONDER TOURNIQUET

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-02-15 for MATRESPONDER TOURNIQUET manufactured by Pyng Medical.

Event Text Entries

[100253975] (b)(4). The device investigation is pending. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10


[100253976] Issue reported: the trauma surgeon who used it is very familiar with the product, having used it extensively both in the hospital and military settings. The case was a major trauma and the surgeon applied the mat t successfully. However, at a certain point he felt the need to tighten the pressure and so he rotated the turnkey again. He admitted that he had never put this much pressure on this product before. What happened after was that the tourniquet suddenly released all of the pressure at once. He is certain that he did not touch the release button. He thought it was a product malfunction so he took another device and did the exact same thing again. Exactly the same thing happened as a result. The patient's condition is unknown at this time.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011137372-2018-00037
MDR Report Key7274553
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-02-15
Date of Report2018-01-25
Date of Event2018-01-24
Date Mfgr Received2018-03-20
Date Added to Maude2018-02-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJASMINE BROWN
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9193614124
Manufacturer G1TELEFLEX MEDICAL
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal Code27560
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMATRESPONDER TOURNIQUET
Generic NameNONPNEUMATIC TOURNIQUET
Product CodeGAX
Date Received2018-02-15
Returned To Mfg2018-02-02
Catalog NumberMATR
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerPYNG MEDICAL


Patients

Patient NumberTreatmentOutcomeDate
10 2018-02-15

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