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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN, FORMERLY TISSUE SCIENCE LABOR UNKNOWN PELVICOL PRODUCT MESH, SURGICAL, POLYMERIC

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COVIDIEN, FORMERLY TISSUE SCIENCE LABOR UNKNOWN PELVICOL PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 482812
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Discomfort (2330); Injury (2348)
Event Type  Injury  
Manufacturer Narrative

Manufacturer reference number: (b)(4). Reoperation, urinary problems, dyspareunia.

 
Event Description

The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. The patient was implanted with a mesh device. After the pelvic mesh device was implanted the patient began to experience severe complications related to the implant, including but not limited to extreme pain, discomfort, urinary problems, dyspareunia and upon information and belief underwent multiple corrective surgeries to remove or revise part of the pelvic mesh device.

 
Event Description

The preoperative and postoperative diagnosis was stress urinary incontinence with hypermobile urethra. The procedure performed was a pubovaginal sling.

 
Manufacturer Narrative

Corrected information: date of birth. If information is provided in the future, a supplemental report will be issued.

 
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Brand NameUNKNOWN PELVICOL PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
COVIDIEN, FORMERLY TISSUE SCIENCE LABOR
victoria house, victoria road
aldershot, hampshire
UK
Manufacturer (Section G)
COVIDIEN, FORMERLY TISSUE SCIENCE LABOR
victoria house, victoria road
aldershot, hampshire
UK
Manufacturer Contact
sharon murphy
60 middletown avenue
north haven, CT 06473
2034925267
MDR Report Key6206661
MDR Text Key63336644
Report Number9617613-2016-00148
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK992556
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/30/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/27/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2008
Device MODEL Number482812
Device Catalogue Number482812
Device LOT Number05B11-1
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 Received04/12/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 12/27/2016 Patient Sequence Number: 1
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