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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 UNKNOWN PELVICOL PRODUCT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cramp(s) (2193); Discharge (2225); Injury (2348); Prolapse (2475); Blood Loss (2597)
Event Type  Injury  
Manufacturer Narrative
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. The product was used for therapeutic treatment of mixed incontinence and symptomatic vaginal wall prolapse. It was reported that after implant, the patient experienced recurrence with recurrent cystocele and rectocele formation, lower abdominal cramping, and bloody vaginal discharge. Post-operative patient treatment included additional surgery. The device had been used with an unknown suburethral sling.
 
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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
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key9606661
MDR Text Key177980047
Report Number9617613-2020-00005
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
Reporter Occupation
Type of Report Initial
Report Date 01/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN PELVICOL PRODUCT
Device Catalogue NumberUNKNOWN PELVICOL PRODUCT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2020
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: 01/20/2020 Patient Sequence Number: 1
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