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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES MESH TSL - PELVICOL¿ MESH, SURGICAL, POLYMERIC

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TISSUE SCIENCE LABORATORIES MESH TSL - PELVICOL¿ MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 482027
Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problems Erosion (1750); Calcium Deposits/Calcification (1758); Low Blood Pressure/ Hypotension (1914); Incontinence (1928); Pain (1994); Sepsis (2067); Injury (2348); Obstruction/Occlusion (2422); Blood Loss (2597); Foreign Body In Patient (2687)
Event Type  Injury  
Manufacturer Narrative
Medtronic complaint report: (b)(4). Additional information: exemption number: e2013003. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Per additional information received, the patient has experienced kidney stone (calcification), low blood pressure/hypotension, elevated temperature, obstruction, sepsis, milky white urine, extrusion, erosion, stress urinary incontinence, mesh exposure, foreign body in patient, blood loss, urinary leakage, pain, additional surgical and nonsurgical interventions.
 
Manufacturer Narrative
Medtronic complaint number: (b)(4). A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. Procedure was a cystoscopy with sling bladder suspension for stress incontinence. On (b)(6) 2015 removal of exposed vaginal mesh, harvest of rectus fascia, placement of rectus fascia sling and cystoscopy performed due to a history of tvt mesh extrusion/erosion into the bladder and stress urinary incontinence.
 
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Brand NameMESH TSL - PELVICOL¿
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
TISSUE SCIENCE LABORATORIES
victoria house, victoria road
aldershot, hampshire GU11 1EJ
GB GU11 1EJ
Manufacturer (Section G)
TISSUE SCIENCE LABORATORIES
victoria house, victoria road
aldershot, hampshire GU11 1EJ
GB GU11 1EJ
Manufacturer Contact
sharon murphy
60 middletown ave
north haven, CT 06473
2034925267
MDR Report Key6758805
MDR Text Key248637071
Report Number9617613-2017-05109
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeMC
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Type of Report Initial,Followup
Report Date 11/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number482027
Device Catalogue Number482027
Device Lot NumberUNKNOWN
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 Received11/07/2017
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

Patient Treatment Data
Date Received: 08/01/2017 Patient Sequence Number: 1
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