MAUDE Adverse Event Report: CP MEDICAL VISORB QUICK; POLYGLYCOLIC ACID ABSORBABLE SYNTHETIC SUTURE

Model Number	VQ493
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported polyglycolic acid fast absorbing suture broke while stitching a patient.(lot# 190213-56) the event occurred during skin surgery but did not cause a delay in procedure.There is no indication of the patient experiencing an adverse event.
Additional Manufacturer Narrative
Report amended to reflect test results from issue sample.
Event or Problem Description
It was reported polyglycolic acid fast absorbing suture broke while stitching a patient.(lot# 190213-56) the event occurred during skin surgery but did not cause a delay in procedure.There is no indication of the patient experiencing an adverse event.

• Brand Name: VISORB QUICK
• Common Device Name: POLYGLYCOLIC ACID ABSORBABLE SYNTHETIC SUTURE
• Manufacturer (Section D): CP MEDICAL; 1775 corporate dr; ste 150; norcross GA 30093
• MDR Report Key: 8723024
• Report Number: 3012164473-2019-00016
• Device Sequence Number: 11227682
• Product Code: GAM
• UDI-Device Identifier: 10790986004112
• UDI-Public: 10790986004112
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K023710
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: VQ493
• Device Catalogue Number: VQ493
• Device Lot Number: 190213-56
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1