MAUDE Adverse Event Report: CP MEDICAL MONOMID; NYLON SURGICAL SUTURE, PRODUCT

Model Number	1669B
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was received regarding part number 1669b lot 200115-54, size 3/0 black nylon (nyl bla swage suture.The customer stated that the sutures had no tensile strength and would easily break just by inserting the suture through the skin.The customer further stated that many surgeries were performed, and that breakages occurred during procedures.According to the customer, most were for closing off incisions.The provider mentioned several patients involved, but an actual count was not provided; there were no reports of delays in the procedures greater than 30 minutes.No further information was obtained from the clinic.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: MONOMID
• Common Device Name: NYLON SURGICAL SUTURE, PRODUCT
• Manufacturer (Section D): CP MEDICAL; 1775 corporate dr; suite 150; norcross GA 30093 2960
• Manufacturer (Section G): CP MEDICAL; 1775 corporate dr; suite 150; norcross GA 30093 2960
• Manufacturer Contact: alfredo ferrer ; 1775 corporate dr; suite 150; norcross, GA 30093-2960
• MDR Report Key: 17878937
• Report Number: 3012164473-2023-00004
• Device Sequence Number: 7456364
• Product Code: GAR
• UDI-Device Identifier: 10790986002521
• UDI-Public: 10790986002521
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K001173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2023

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: 12/31/2024
• Device Model Number: 1669B
• Device Catalogue Number: 1669B
• Device Lot Number: 200115-54
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2022
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown