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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
Device Problems Break (1069); Product Quality Problem (1506)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/28/2019
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event 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 NameMONOSOF
Type of DeviceSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
Manufacturer (Section D)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven CT 06473
Manufacturer (Section G)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven CT 06473
Manufacturer Contact
lisa hernandez
60 middletown ave.
north haven, CT 06473
2034925563
MDR Report Key8810104
MDR Text Key151712983
Report Number1219930-2019-04254
Device Sequence Number1
Product Code GAR
Combination Product (Y/N)N
Reporter Country CodeBE
PMA/PMN NumberK900531
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 07/21/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/21/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN-2532
Device Catalogue NumberN-2532
Device LOT NumberA8F0532X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/03/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/15/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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