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

Model Number	VQ535-HUF
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the needle detached from pga suture after initial pass through tissue.There was no indication of the patient experiencing an adverse event.The suture involved came from lot# 180108-63.

• Brand Name: VISORB SWIFT
• Common Device Name: POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SUTURE
• Manufacturer (Section D): CP MEDICAL; 1775 corporate dr; ste 150; norcross GA 30093
• MDR Report Key: 8298485
• Report Number: 3012164473-2019-00013
• Device Sequence Number: 13857909
• Product Code: GAM
• UDI-Device Identifier: 10889950001452
• UDI-Public: 10889950001452
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/01/2019

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: 12/31/2021
• Device Model Number: VQ535-HUF
• Device Catalogue Number: VQ535-HUF
• Device Lot Number: 180108-63
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2019
• Initial Report FDA Received Date: 02/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1