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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CP MEDICAL PGA; POLYGLYCOLIC ACID ABSORBABLE SYNTHETIC SUTURE,
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CP MEDICAL PGA; POLYGLYCOLIC ACID ABSORBABLE SYNTHETIC SUTURE, Back to Search Results
Model Number 494A
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Event or Problem Description
It was reported size 4/0 polyglycolic acid suture tearing or fraying.(lot# 190423-53) 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 refelect test results from issue sample.
 
Event or Problem Description
It was reported size 4/0 polyglycolic acid suture tearing or fraying.(lot# 190423-53) there was patient involvement but no indication of an adverse event.The surgery wasn't delayed greater than 30 minutes.
 
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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 Key9131080
Report Number3012164473-2019-00022
Device Sequence Number10860404
Product Code GAM
UDI-Device Identifier10790986000657
UDI-Public10790986000657
Combination Product (Y/N)N
Initial Reporter StateIA
Initial Reporter CountryUS
PMA/510(K) Number
K002190
Number of Events Summarized1
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) 11/06/2019
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 Date03/31/2024
Device Model Number494A
Device Catalogue Number494A
Device Lot Number190423-53
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/14/2019
Initial Date Received by Manufacturer 08/30/2019
Supplement Date Received by Manufacturer08/30/2019
Initial Report FDA Received Date09/27/2019
Supplement Report FDA Received Date11/06/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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