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U.S. Department of Health and Human Services

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

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TISSUE SCIENCE LABORATORIES PELVICOL MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 482047
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Incontinence (1928); Pain (1994); Urinary Retention (2119); Weakness (2145); Injury (2348); Numbness (2415); Prolapse (2475); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This event was previously reported to the fda on an alternative summary report (asr approval #: (b)(4)) which is no longer in effect. Because of additionally received complaint information, this and all further updates will be submitted through the 3500a form. (b)(4). 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 vaginal wall prolapse and stress urinary incontinence. It was reported that after implant, the patient experienced right medial thigh pain, pain shooting into vagina, paresthesia with numbness, voiding difficulty, pelvic pain, pelvic plexopathy, clinical weakness involving both lower limbs, urge and stress urinary incontinence, vaginismus, dyspareunia, and stage ii rectocele. Post-operative patient treatment included rectocele repair, sling removal, enterocele repair, cystoscopy.
 
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Brand NamePELVICOL
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 Key9661750
MDR Text Key177636028
Report Number9617613-2020-00024
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 02/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/07/2009
Device Model Number482047
Device Catalogue Number482047
Device Lot Number06B23-1
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: 02/03/2020 Patient Sequence Number: 1
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