MAUDE Adverse Event Report: CP MEDICAL GREEN POLYESTER BRAIDED NON-ABSORBABLE SUTURE; CP588A - POLYBOND

Model Number	CP588A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Description of the defect, malfunction or error in use of the device: on july 31, 2024, customer service received a complaint from (b)(6) medical center regarding product cp588a-nor, size 3/0 pe grn suture, which was reported to have pledgets attached to the suture.Based on cp medical's bill of materials (bom), this product code does not require pledgets.

• Brand Name: GREEN POLYESTER BRAIDED NON-ABSORBABLE SUTURE
• Common Device Name: CP588A - POLYBOND
• Manufacturer (Section D): CP MEDICAL; 1775 corporate dr; suite 150; norcross GA 30093
• Manufacturer Contact: alfredo ferrer ; 1775 corporate dr; suite 150; norcross, GA 30093-2960
• MDR Report Key: 20023925
• Report Number: 3012164473-2024-00005
• Device Sequence Number: 7364068
• Product Code: GAT
• UDI-Device Identifier: 10790986004358
• UDI-Public: (01)10790986004358
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K001172
• 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
• Report Date (Section B): 07/31/2024

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: CP588A
• Device Lot Number: 230314-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2023
• 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