MAUDE Adverse Event Report: NORTH AMERICAN RESCUE NAR RESPONDER EMERGENCY TRAUMA DRESSING; BANDAGE

Model Number 30-0171

Device Problems Nonstandard Device (1420); Defective Device (2588)

Patient Problem Not Applicable (3189)

Event Date 07/29/2020

Event Type  malfunction  

Event Description

(b)(4) was held under notice of fda action.These products were sampled and analyzed.The lab findings are viable microorganisms detected in 4 of 40 unites tested.

• Brand Name: NAR RESPONDER EMERGENCY TRAUMA DRESSING
• Type of Device: BANDAGE
• Manufacturer (Section D): NORTH AMERICAN RESCUE; 35 tedwall ct; greer, sc
• Manufacturer (Section G): NORTH AMERICAN RESCUE, LLC; 35 tedwall ct; greer, sc
• Manufacturer Contact: william slevin ; 35 tedwall ct; greer, sc ; 6759800
• MDR Report Key: 10457180
• MDR Text Key: 221573273
• Report Number: 3005034064-2020-00002
• Device Sequence Number: 1
• Product Code: FQM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 30-0171
• Device Catalogue Number: 30-0171
• Device Lot Number: TSD2419
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 3005034064-08/20/20-001R
• Patient Sequence Number: 1