SWAT-T

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-08-21 for SWAT-T manufactured by Tems Solutions.

Event Text Entries

[4799512] Patient was a soldier in (b)(6), struck by bomb blast leading to bilateral lower extremity near-complete amputations. Unit's medic (special forces trained, very competent and experienced) attempted application of swat-t (stretch-wrap-and-tuck tourniquet) to lower extremities, tearing 2 separate, brand new tourniquets. Medic then successfully supplied several cat/soft-t tourniquets, patient arrested and expired about 20-30mins there after. Cause of death a combination of blast injuries and hypovolemia. (b)(6). Joint operational evaluation of field tourniquets (joeft) - phase ii, report (b)(4). Pending publication. - report cites multiple swat-t failures in most ideal conditions, including several episodes of tearing. While investigating circumstances surrounding soldier's death, it was discovered the swat-t had been marketed amongst the soldier's unit and community as better than the cat or soft-t. Though it was common knowledge amongst the soldiers that the tourniquets frequently tore. There are no other specific documented cases of pre-hospital tourniquet failures at this time that i'm aware of, mainly because none of those other failures resulted in death.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5037903
• MDR Report Key: 4037683
• Date Received: 2014-08-21
• Date of Report: 2014-08-20
• Date of Event: 2014-06-09
• Date Added to Maude: 2014-08-26
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• 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: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SWAT-T
• Generic Name: TOURNIQUET
• Product Code: GAX
• Date Received: 2014-08-21
• Operator: HEALTH PROFESSIONAL
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: TEMS SOLUTIONS
• Manufacturer Address: 22619 MONTEGO BAY ROAD 24211 24211

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2014-08-21