MAUDE Adverse Event Report: CP MEDICAL MONOSWIFT; PGCL

Model Number	L922
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report is for unknown patient 1:2.[(b)(4)].
Event or Problem Description
It was reported that pgcl suture associated with lot# 180523-52 and lot# 180131-50 were breaking while being tied down and needle detaching after initial pass.This failure occurred with 2 patients during oral surgery.The patients did not experience any adverse effects.

• Brand Name: MONOSWIFT
• Common Device Name: PGCL
• Manufacturer (Section D): CP MEDICAL; 1775 corporate dr; ste 150; norcross GA 30093
• MDR Report Key: 8213896
• Report Number: 3012164473-2019-00011
• Device Sequence Number: 223289
• Product Code: GAM
• UDI-Device Identifier: 10790986001494
• UDI-Public: 10790986001494
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K072229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/03/2019

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: 10/31/2019
• Device Model Number: L922
• Device Catalogue Number: L922
• Device Lot Number: 180523-52
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 01/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1