MAUDE Adverse Event Report: Z-MEDICA, LLC QUIK CLOT CONTROL + 5X5 ; DRESSING, WOUND, DRUG

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 03/26/2020

Event Type  malfunction  

Event Description

Per the z-medica, llc.Product representative, some of the quik clot products are intended to be used externally only.These product labels do not reflect that indication on the label.The label does not state "for external use only".Other quik clot products are indicated for internal use.Those product labels do not indicate that they are intended to be used internally only.The products labels do not clearly delineate how the manufacturer has intended for the product to be used.Quik clot products are labeled as x-ray detectable.Products that are x-ray detectable are made with radiopaque portions which allows the product to be identified by x-ray to prevent retention of foreign bodies.Quik clot products are designed with radiopaque material to allow the product to be identified by x-ray.The quik clot control + 5x5 product has a minimal portion of radiopaque material which may impact its ability to be detected upon x-ray.The product may be improved by increasing the radiopaque portions to make them x-ray detectable.

• Brand Name: QUIK CLOT CONTROL + 5X5
• Type of Device: DRESSING, WOUND, DRUG
• Manufacturer (Section D): Z-MEDICA, LLC
• MDR Report Key: 10069615
• MDR Text Key: 191551657
• Report Number: MW5094533
• Device Sequence Number: 3
• Product Code: FRO
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/14/2020
• 7 Devices were Involved in the Event: 1 2 3 4 5 6 7

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR