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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN MONOSOF; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
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COVIDIEN LP LLC NORTH HAVEN MONOSOF; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE Back to Search Results
Model Number N-2532
Medical Device Problem Codes Break (1069); Product Quality Problem (1506)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/28/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, during an open diep flap procedure, the device, needle was not sharp and the thread broke.The surgeon then used another device to resolve the issue in order to complete the case.There was no patient injury.
 
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Brand Name
MONOSOF
Common Device Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
Manufacturer (Section D)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven CT 06473
MDR Report Key8810104
Report Number1219930-2019-04254
Device Sequence Number3206000
Product Code GAR
UDI-Device Identifier20884521075990
UDI-Public20884521075990
Combination Product (Y/N)N
Initial Reporter CountryBE
PMA/510(K) Number
K900531
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/21/2019
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 Date06/30/2023
Device Model NumberN-2532
Device Catalogue NumberN-2532
Device Lot NumberA8F0532X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/03/2019
Initial Report FDA Received Date07/21/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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