MAUDE Adverse Event Report: CP MEDICAL MONOMID, POLYAMID; NYLON NON-ABSORBABLE SUTURE

Model Number	667B
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
"the sutures broke during the doctors surgeries.".

• Brand Name: MONOMID, POLYAMID
• Common Device Name: NYLON NON-ABSORBABLE SUTURE
• Manufacturer (Section D): CP MEDICAL; 1775 corporate drive, ste. 150; norcross GA 30093
• MDR Report Key: 7531400
• Report Number: 3012164473-2018-00002
• Device Sequence Number: 18890426
• Product Code: GAR
• UDI-Device Identifier: 10790986002309
• UDI-Public: 10790986002309
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K001173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial

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?: No
• Operator of Device: No Information
• Device Model Number: 667B
• Device Catalogue Number: 667B
• Device Lot Number: 171010-60
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 05/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention