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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CP MEDICAL POLYPROPYLENE; POLYPROPYLENE NONABSORBABLE SYNTHETIC SUTURE,
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CP MEDICAL POLYPROPYLENE; POLYPROPYLENE NONABSORBABLE SYNTHETIC SUTURE, Back to Search Results
Model Number 8682P-CP1
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that size 4/0 polypropylene suture broke during normal procedure.The distributor has been contacted several times and hasn't provided details of the event.The only known information is the product number.(8682p) either lot# 190425-56 or lot# 181227-54 is associated with the event.Testing and investigation was completed on both lots for documentation purposes.If additional information is received a supplemental mdr will be submitted.
 
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Brand Name
POLYPROPYLENE
Common Device Name
POLYPROPYLENE NONABSORBABLE SYNTHETIC SUTURE,
Manufacturer (Section D)
CP MEDICAL
1775 corporate dr
ste 150
norcross GA 30093
MDR Report Key9131345
Report Number3012164473-2019-00023
Device Sequence Number606712
Product Code GAW
UDI-Device Identifier10790986003559
UDI-Public10790986003559
Combination Product (Y/N)N
Initial Reporter StateIA
Initial Reporter CountryUS
PMA/510(K) Number
K001185
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) 09/27/2019
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 Number8682P-CP1
Device Catalogue Number8682P-CP1
Device Lot Number190425-56
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/30/2019
Initial Report FDA Received Date09/27/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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