MAUDE Adverse Event Report: Z-MEDICA, LLC QUIKCLOT CONTROL+ 12X12 PAD; 12X12 LAP SPONGE

Model Number	4030
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Two quikclot control+ 12x12 pads were inadvertently left inside the patient followed surgery and required additional surgery to remove.The instructions for use (ifu) state the following: contraindications: do not leave quikclot control+ in place for more than 48 hours.Warnings: quikclot control+ dressing is not absorbable and must be removed from wound prior to closure.This is the first and only report of this nature concerning the quikclot control+ dressings since the products were introduced in 2017.This isolated incident has been attributed to use of the product in a manner not consistent with the instructions for use.
Event or Problem Description
Z-medica, llc received a medwatch form from the hospital on 5/21/2021.The report alleged the there were retained laparotomy pads.The patient had exploratory laparoscopy for a suspected perforated descending colon.The patient had a vast amount of cancerous tissue that need to be removed.During the surgery the patient had total abdominal colectomy, omenectomy, appendectomy, bso, hysterectomy, and an end ileostomy created on (b)(6) 2021.Quikclot control+ dressings were placed deep in the pelvis to help with hemostasis.The hospital report that all counts were correct at the end of the case.The patient had a delayed return of bowel function and a ct was performed on (b)(6) 2021.Which showed retained lap pads.The patient was taken into surgery on (b)(6) 2021 for removal of the foreign objects.One lap sponge was found in the pelvis and the other in the right paracolic gutter.The patient had an uneventful surgery and was discharged on (b)(6) 2021.The customer "opined that the x-ray detectable on the label was not prominent and staff may think sponges do not need to be counted".

• Brand Name: QUIKCLOT CONTROL+ 12X12 PAD
• Common Device Name: 12X12 LAP SPONGE
• Manufacturer (Section D): Z-MEDICA, LLC; 4 fairfield boulevard; wallingford CT 06492
• MDR Report Key: 11957318
• Report Number: 3004138549-2021-00002
• Device Sequence Number: 3724748
• Product Code: POD
• UDI-Device Identifier: 00841495140303
• UDI-Public: 00841495140303
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: DEN160012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/08/2021

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 Expiration Date: 11/28/2022
• Device Model Number: 4030
• Device Catalogue Number: 4030
• Device Lot Number: 10749
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 06/08/2021
• 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: Required Intervention
• Patient Age: 59 YR
• Patient Weight: 55