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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON UNKNOWN URETEX MESH PRODUCT MESH, SURGICAL

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COVIDIEN, FORMERLY US SURGICAL A DIVISON UNKNOWN URETEX MESH PRODUCT MESH, SURGICAL Back to Search Results
Model Number URETEX SUPPORT PP KIT X1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)
Event Date 06/26/2006
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. The patient experienced erosion of the mesh one month post-operatively and had to have reoperation. Seven months later, the patient had another reoperation due to small erosion of mesh inside bladder. One year after the second reoperation, patient had to go into surgery due to a partial occlusion of the ureter.
 
Manufacturer Narrative
(b)(4).
 
Event Description
On (b)(6) 2006: underwent cystourethroscopy, pelvic under anesthesia, revision and removal of ectopic mesh for erosion of vaginal mesh. On (b)(6) 2007: underwent cystourethroscopy with sounding, pelvic under anesthesia, excision and removal of mesh from inside the bladder for possible erosion of mesh from previous apogee perigee repair. On (b)(6) 2008: underwent cystoscopy, insertion of ureteric catheters, partial cystectomy, cystotomy, cystorrhaphy for mesh in bladder, foreign body in bladder, voiding dysfunction under general and endotracheal intubation.
 
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Brand NameUNKNOWN URETEX MESH PRODUCT
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
COVIDIEN, FORMERLY US SURGICAL A DIVISON
60 middletown ave
north haven CT 06473
Manufacturer (Section G)
COVIDIEN, FORMERLY US SURGICAL A DIVISON
60 middletown ave
north haven CT 06473
Manufacturer Contact
sharon murphy
60 middletown ave
north haven, CT 06473
MDR Report Key6086012
MDR Text Key59450934
Report Number1219930-2016-01165
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2011
Device Model NumberURETEX SUPPORT PP KIT X1
Device Catalogue NumberURETEXSUP
Device Lot NumberSGB00409
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 Received11/11/2016
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

Patient Treatment Data
Date Received: 11/08/2016 Patient Sequence Number: 1
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