MAUDE Adverse Event Report: Z-MEDICA, LLC QC HEMOSTATIC DRESSING, 4X4, 10X; DRESSING, WOUND, DRUG

Model Number	0459
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device is not expected for return to be investigated.Teleflex will continue to monitor and trend related events.
Event or Problem Description
It was reported that a 4x4 quik clot was left behind in patient and closed during an ortho spine case on (b)(6) 2022.Additional information: it was reported that 2-3 weeks after the initial surgery the patient had a post-op visit and it was discovered that the sponge had been left inside the patient.No physical signs or symptoms were described in this report.The patient had an overnight hospital stay after the surgery to remove the sponge.The patient's current condition post-op was reported as "no issues have been reported" and it is unknown if any antibiotics or other treatment was provided.
Event or Problem Description
It was reported that a 4x4 quik clot was left behind in patient and closed during an ortho spine case on 28jul2022.Additional information: it was reported that 2-3 weeks after the initial surgery the patient had a post-op visit and it was discovered that the sponge had been left inside the patient.No physical signs or symptoms were described in this report.The patient had an overnight hospital stay after the surgery to remove the sponge.The patient's current condition post-op was reported as "no issues have been reported" and it is unknown if any antibiotics or other treatment was provided.
Additional Manufacturer Narrative
(b)(4).No product returned to evaluate.Visual , dimensional, and functional examination would have no impact to the product based upon noted complaint statement.No lot number was provided therefore a review of the dhr (device history record) could not be performed.Review of the ifu has determined the following warning has been present since product launch: warnings: product is not absorbable and must be removed from wound prior to wound closure.The user did not follow instructions and warnings listed in ifu.This complaint is the result of user error.

• Brand Name: QC HEMOSTATIC DRESSING, 4X4, 10X
• Common Device Name: DRESSING, WOUND, DRUG
• Manufacturer (Section D): Z-MEDICA, LLC; wallingford
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15828378
• Report Number: 3011137372-2022-00214
• Device Sequence Number: 6109253
• Product Code: FRO
• UDI-Device Identifier: 00841495104596
• UDI-Public: 00841495104596
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K123387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2022

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 Model Number: 0459
• Device Catalogue Number: 459
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2022
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Age: 62 YR
• Patient Sex: Female