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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN MESH BALLYMONEY - IVS TUNNELLER MESH, SURGICAL, POLYMERIC

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COVIDIEN LP LLC NORTH HAVEN MESH BALLYMONEY - IVS TUNNELLER MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN IVS TUNNELLER DEVICE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Prolapse (2475); No Code Available (3191)
Event Date 04/28/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter, after posterior mesh repair on (b)(6) 2006, the patient had vaginal pain and groin pain/ dyspareunia.

 
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Brand NameMESH BALLYMONEY - IVS TUNNELLER
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 Key10105618
MDR Text Key193068837
Report Number1219930-2020-02217
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 COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 06/01/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/01/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNKNOWN IVS TUNNELLER DEVICE
Device Catalogue NumberUNKNOWN IVS TUNNELLER DEVICE
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2020
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

Patient TREATMENT DATA
Date Received: 06/01/2020 Patient Sequence Number: 1
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