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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN NORTH HAVEN - MFG HERNIA KIT

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COVIDIEN NORTH HAVEN - MFG HERNIA KIT Back to Search Results
Model Number K2953
Device Problem Inflation Problem (1310)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
According to the reporter, during a laparoscopic procedure, the balloon did not inflate. A new structural balloon was used in order to complete the case. There was no patient injury involved.
 
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Brand NameHERNIA KIT
Manufacturer (Section D)
COVIDIEN NORTH HAVEN - MFG
195 mcdermott road
north haven CT 06473
Manufacturer (Section G)
COVIDIEN NORTH HAVEN - MFG
195 mcdermott road
north haven CT 06473
Manufacturer Contact
sharon murphy
60 middletown avenue
north haven, CT 06473
2034925267
MDR Report Key6779023
MDR Text Key82577321
Report Number1219930-2017-06275
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial
Report Date 07/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Model NumberK2953
Device Catalogue NumberK2953
Device Lot Number0008649696
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 Received07/10/2017
Was Device Evaluated by Manufacturer? No Answer Provided
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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