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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 496A-CP1
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 pga suture being weak and fraying upon use.(lot# 190501-51) there was patient involvement but no indication of an adverse event.The surgery wasn't delayed greater than 30 minutes.
 
Event or Problem Description
It was reported size 4/0 pga suture being weak and fraying upon use.(lot# 190501-51) 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 from issue sample.
 
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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 Key9470125
Report Number3012164473-2019-00033
Device Sequence Number11387869
Product Code GAM
UDI-Device Identifier10790986000671
UDI-Public10790986000671
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) 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 Date04/30/2024
Device Model Number496A-CP1
Device Catalogue Number496A-CP1
Device Lot Number190501-51
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2019
Initial Date Received by Manufacturer 11/13/2019
Supplement Date Received by Manufacturer11/13/2019
Initial Report FDA Received Date12/13/2019
Supplement Report FDA Received Date01/16/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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