MAUDE Adverse Event Report: Z-MEDICA, LLC QUIKCLOT HEMOSTATIC DRESSING; DRESSING, WOUND, DRUG

Catalog Number	0086
Medical Device Problem Codes	Material Disintegration (1177); Entrapment of Device (1212); Device Markings/Labelling Problem (2911); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Quikclot was retained internally in the patient's leg after being applied to an open fasciotomy of the right calf on (b)(6) 2020.The patient underwent surgeries on (b)(6) to remove the quikclot gauze and packing fibers because it was stuck in the deeper tissue and had disintegrated into small pieces.The quikclot was identified through an mri, and the foreign material that was visible to the surgeon was completely removed.The label on the quikclot package does not mention it is for 24 hour use, which could have led to this user error.It is printed on the mifu, which is discarded before supply technicians place the product on shelves.Further, more specific labeling is recommended.Fda safety report id# (b)(4).

• Brand Name: QUIKCLOT HEMOSTATIC DRESSING
• Common Device Name: DRESSING, WOUND, DRUG
• Manufacturer (Section D): Z-MEDICA, LLC ; wallingford CT 06492
• MDR Report Key: 11343828
• Report Number: MW5099466
• Device Sequence Number: 2845360
• Product Code: FRO
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0086
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Weight: 107