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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 UNK PELVICOL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Discomfort (2330); Injury (2348)
Event Date 04/21/2005
Event Type  Injury  
Manufacturer Narrative

(b)(4). (b)(6). (b)(4).

 
Event Description

The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. Patient underwent multiple corrective surgeries, removal of part of the pelvic mesh device. Extreme pain, discomfort, urinary problems, dyspareunia.

 
Manufacturer Narrative

After review it was determined that this report is a duplicate of mfr#9617613-2016-00129. All further updates will be reported under mfr#9617613-2016-00129.

 
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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 ave
north haven, CT 06473
MDR Report Key6197976
MDR Text Key63070601
Report Number9617613-2016-00144
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/30/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/22/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberUNK PELVICOL
Device Catalogue NumberUNK PELVICOL
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 Received11/30/2016
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

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