MAUDE Adverse Event Report: CP MEDICAL POLYPROPYLENE; POLYPROPYLENE NONABSORBABLE SYNTHETIC SUTURE

Model Number	1011P-HUF
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that size 6/0 polypropylene suture broke during a procedure within a patient's mouth.(lot# 180404-56) there was patient involvement but no indictation of an adverse event.The procedure wasnt delayed greater than 30 minutes.

• Brand Name: POLYPROPYLENE
• Common Device Name: POLYPROPYLENE NONABSORBABLE SYNTHETIC SUTURE
• Manufacturer (Section D): CP MEDICAL; 1775 corporate dr; ste 150; norcross GA 30093
• MDR Report Key: 9566614
• Report Number: 3012164473-2020-00001
• Device Sequence Number: 2362201
• Product Code: GAW
• UDI-Device Identifier: 10889950001865
• UDI-Public: 10889950001865
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K001185
• 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
• Report Date (Section B): 01/08/2020

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: 03/31/2023
• Device Model Number: 1011P-HUF
• Device Catalogue Number: 1011P-HUF
• Device Lot Number: 180404-56
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 01/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1