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

Catalog Number 0086

Device Problems Material Disintegration (1177); Entrapment of Device (1212); Device Markings/Labelling Problem (2911); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/17/2020

Event Type  Injury  

Event 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
• Type of Device: DRESSING, WOUND, DRUG
• Manufacturer (Section D): Z-MEDICA, LLC ; wallingford CT 06492
• MDR Report Key: 11343828
• MDR Text Key: 232903515
• Report Number: MW5099466
• Device Sequence Number: 1
• Product Code: FRO
• 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: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 107