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

Model Number	392A-HUF
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 4/0 polyglycolic acid suture breaking during surgery.(lot# 171208-55) there was patient involvement but no indication of an adverse event.The surgery wasn't delayed greater than 30 minutes.The exact number of patient(s) involved is unknown.

• 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: 8899089
• Report Number: 3012164473-2019-00020
• Device Sequence Number: 205649
• Product Code: GAM
• UDI-Device Identifier: 10889950001285
• UDI-Public: 10889950001285
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 08/15/2019

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: 05/31/2020
• Device Model Number: 392A-HUF
• Device Catalogue Number: 392A-HUF
• Device Lot Number: 171208-55
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2019
• Initial Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1