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,health report with the FDA on 2018-05-02 for MATRESPONDER TOURNIQUET manufactured by Pyng Medical.

Event Text Entries

[107118844] (b)(4). The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10


[107118845] It was reported that during a motorcycle accident the ems was trying to stop the bleeding on the patient. When he began to wind the tourniquet, it snapped and was unable to stop the bleeding, and a belt was used instead. The patient ended up with a left below the knee amputation.
Patient Sequence No: 1, Text Type: D, B5


[132605626] (b)(4). A device history record review could not be performed as no lot number was provided. The ifu provided with this product notifies the user to reset the tourniquet before each application. Corrective action is not required at this time as the probable cause could not be determined based upon the information provided and without a sample. Complaint verification testing could not be performed as no sample was returned for analysis. A device history record review could not be performed since a correct lot number was not provided by the customer. Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information. Teleflex will continue to monitor and trend for reports of this nature.
Patient Sequence No: 1, Text Type: N, H10


[132605627] It was reported that during a motorcycle accident the ems was trying to stop the bleeding on the patient. When he began to wind the tourniquet, it snapped and was unable to stop the bleeding, and a belt was used instead. The patient ended up with a left below the knee amputation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011137372-2018-00110
MDR Report Key7479861
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-05-02
Date of Report2018-04-12
Date of Event2018-04-08
Date Mfgr Received2018-05-16
Date Added to Maude2018-05-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPARAMEDIC
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 Received2018-05-02
Catalog NumberMATR
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPYNG MEDICAL


Patients

Patient NumberTreatmentOutcomeDate
10 2018-05-02

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