MAUDE Adverse Event Report: CP MEDICAL MONOSWIFT; PGCL

Model Number	L496
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that pgcl sutures, associated with lot# 171006-63 were breaking while being tied down.This failure occurred with 4 patients between the age range of (b)(6) and in good health.There were no adverse effects associated with pgcl sutures.The surgeries was delayed for 1 minute and finished with another unknown suture.

• Brand Name: MONOSWIFT
• Common Device Name: PGCL
• Manufacturer (Section D): CP MEDICAL; 1775 corporate dr; ste 150; norcross GA 30093
• MDR Report Key: 8122175
• Report Number: 3012164473-2018-00007
• Device Sequence Number: 1244395
• Product Code: GAM
• UDI-Device Identifier: 10790986001449
• UDI-Public: 10790986001449
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K072229
• 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): 11/30/2018

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: 03/31/2019
• Device Model Number: L496
• Device Catalogue Number: L496
• Device Lot Number: 171006-63
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 12/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1