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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN

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COVIDIEN LP LLC NORTH HAVEN Back to Search Results
Model Number UNKNOWN - SUTURE
Device Problem Break (1069)
Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)
Event Date 10/27/2017
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 a perineal incision suture, at the time of stitching, the patient reported that the pain was unbearable. After examination, the needle was found to have no needle tip. Another needle was used to complete the case. The patient's pain was aggravated by suture.
 
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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 Key7665356
MDR Text Key113638107
Report Number1219930-2018-03642
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Reporter Country CodeCH
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 07/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN - SUTURE
Device Catalogue NumberUNKNOWN - SUTURE
Device Lot Number20170305
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2017
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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