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

Model Number	494A
Health Effect - Clinical Code	Wound Dehiscence (1154)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Record represent 1:3 patients involved with issue sample.There is a pending voluntarily elected recall for lot# 190123-59 due to its failure to meet usp tensile strength specification.
Event or Problem Description
It was reported that size 4/0 polyglycolic acid suture snapped easily and knots were not holding.(lot# 190123-59) three patients subsequently experienced dehiscence of wounds.The clinic has been contacted multiple times in attempt to retrieve information regarding each patient's event.If additional information is received a supplemental mdr will be submitted.

• 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: 9214955
• Report Number: 3012164473-2019-00026
• Device Sequence Number: 2167518
• Product Code: GAM
• UDI-Device Identifier: 10790986000657
• UDI-Public: 10790986000657
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 10/16/2019

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: 12/31/2023
• Device Model Number: 494A
• Device Catalogue Number: 494A
• Device Lot Number: 190123-59
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 10/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1