MAUDE Adverse Event Report: CP MEDICAL CHROMIC GUT NATURAL ABSORBABLE SUTURE

Model Number	558CG
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to brad welsh dentistry,there were multiple suture breaks during tooth extraction surgeries.The clinic also noticed that the suture appeared to be a different color than normal compared to previous suture lots received.The clinic reports that this incident happened several times with multiple lot numbers for the 558cg product code, but these lot numbers were not reported to cp medical the procedure did not experience a delay greater than 30 minutes; however, this was an inconvenience for the user.No patients were harmed.

• Brand Name: CHROMIC GUT NATURAL ABSORBABLE SUTURE
• Common Device Name: CHROMIC GUT
• 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: 19749693
• Report Number: 3012164473-2024-00003
• Device Sequence Number: 18396184
• Product Code: GAL
• UDI-Device Identifier: 10790986001777
• UDI-Public: (01)10790986001777
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K001299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 558CG
• Device Lot Number: 231128-52
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2024
• 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