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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 Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
1:3 lots associated with report - attachment: [lot# 190123-59 return sample tensile test.Pdf, lot# 190123-59 retain sample tensile test.Pdf].
 
Event or Problem Description
It was reported polyglycolic acid suture breaking while tying knots.(lot# 190123-59) the doctor has been contacted several times and is unwilling to provide details of the events.There is no indication of the patient experiencing an adverse event.
 
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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 Key8755889
Report Number3012164473-2019-00017
Device Sequence Number2040734
Product Code GAM
UDI-Device Identifier10790986000657
UDI-Public10790986000657
Combination Product (Y/N)N
Initial Reporter StateFL
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
Report Date (Section B) 07/02/2019
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 Date12/31/2023
Device Model Number494A
Device Catalogue Number494A
Device Lot Number190123-59
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/27/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/04/2019
Initial Report FDA Received Date07/02/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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