MAUDE Adverse Event Report: CP MEDICAL PGA; POLYGLYCOLIC ACID ABSORBABLE SYNTHETIC SUTURE

Model Number	492A-CP1
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported size 6/0 pga suture being weak and fraying upon use.(lot# 190108-52) there was patient involvement but no indication of an adverse event.The surgery wasn't delayed greater than 30 minutes.
Additional Manufacturer Narrative
Report amended to reflect test results of issue sample.- attachment: [lot# 190108-52 retain sample tensile test.Pdf, lot# 190108-52 return sample tensile test.Pdf].
Event or Problem Description
It was reported size 6/0 pga suture being weak and fraying upon use.(lot# 190108-52) there was patient involvement but no indication of an adverse event.The surgery wasn't delayed greater than 30 minutes.

• Brand Name: PGA
• Common Device Name: POLYGLYCOLIC ACID ABSORBABLE SYNTHETIC SUTURE
• Manufacturer (Section D): CP MEDICAL; 1775 corporate dr; ste 150; norcross GA 30093
• MDR Report Key: 9470133
• Report Number: 3012164473-2019-00032
• Device Sequence Number: 2474808
• Product Code: GAM
• UDI-Device Identifier: 10790986000633
• UDI-Public: 10790986000633
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K002190
• 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,Followup
• Report Date (Section B): 01/16/2020

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: 12/31/2023
• Device Model Number: 492A-CP1
• Device Catalogue Number: 492A-CP1
• Device Lot Number: 190108-52
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 01/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1