MAUDE Adverse Event Report: CP MEDICAL POLYPROPYLENE NONABSORBABLE SURGICAL SUTURE

Model Number	1011P-HUF
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported polypropylene suture was breaking while in patient's mouth.(lot # 180611-65).The event occurred during surgery but did not cause a delay in procedure.There is no indication of the patient experiencing an adverse event.

• Brand Name: POLYPROPYLENE NONABSORBABLE SURGICAL SUTURE
• Common Device Name: POLYPROPYLENE
• Manufacturer (Section D): CP MEDICAL; 1775 corporate dr; ste 150; norcross GA 30093
• MDR Report Key: 8651047
• Report Number: 3012164473-2019-00015
• Device Sequence Number: 2246797
• 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): 05/29/2019

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: 05/31/2023
• Device Model Number: 1011P-HUF
• Device Catalogue Number: 1011P-HUF
• Device Lot Number: 180611-65
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 05/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1