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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN SURGIPRO MESH, SURGICAL, POLYMERIC

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COVIDIEN LP LLC NORTH HAVEN SURGIPRO MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number SMPL-01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/27/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, the units were suspected to have adverse events.
 
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Brand NameSURGIPRO
Type of DeviceMESH, SURGICAL, POLYMERIC
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 Key7464390
MDR Text Key106607462
Report Number1219930-2018-02292
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K982575
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial
Report Date 04/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2022
Device Model NumberSMPL-01
Device Catalogue NumberSMPL-01
Device Lot NumberA7C0866X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/02/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/24/2017
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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