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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CP MEDICAL MONOSWIFT; PGCL
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CP MEDICAL MONOSWIFT; PGCL Back to Search Results
Model Number L496
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Report is for unknown male patient #3 associated with mfr report# 3012164473-2018-00007.
 
Event or Problem Description
It was reported that pgcl sutures, associated with lot# 171006-63 were breaking while being tied down.This failure occurred with 4 patients between the age range of mid (b)(6) years old and in good health.There were no adverse effects associated with pgcl sutures.The surgeries was delayed for 1 minute and finished with another unknown suture.
 
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Brand Name
MONOSWIFT
Common Device Name
PGCL
Manufacturer (Section D)
CP MEDICAL
1775 corporate dr
ste 150
norcross GA 30093
MDR Report Key8122170
Report Number3012164473-2018-00009
Device Sequence Number295573
Product Code GAM
UDI-Device Identifier10790986001449
UDI-Public10790986001449
Combination Product (Y/N)N
Initial Reporter StateMO
Initial Reporter CountryUS
PMA/510(K) Number
K072229
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 11/30/2018
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 Date03/31/2019
Device Model NumberL496
Device Catalogue NumberL496
Device Lot Number171006-63
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/28/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/02/2018
Initial Report FDA Received Date12/01/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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