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U.S. Department of Health and Human Services

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

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TISSUE SCIENCE LABORATORIES MESH TSL - PERMACOL¿ MESH, SURGICAL Back to Search Results
Model Number P101010
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Diarrhea (1811); Incontinence (1928); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Discomfort (2330); Injury (2348); Prolapse (2475); Blood Loss (2597); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(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 pelvic relaxation and large rectocele. It was reported that after implant, the patient experienced recurrent urinary tract infections, incontinence, dyspareunia, cystocele, prolapse, vagina has dropped further, pelvic floor dysfunction, right flank pain, watery diarrhea, urinary retention, decreased libido, menopausal symptoms, vaginal discomfort, vaginal bleeding and vaginal atrophy. Post-operative patient treatment included additional surgery.
 
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Brand NameMESH TSL - PERMACOL¿
Type of DeviceMESH, SURGICAL
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 Key8848616
MDR Text Key152908850
Report Number9617613-2019-00131
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120605
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 07/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/13/2011
Device Model NumberP101010
Device Catalogue NumberP101010
Device Lot Number07B11-9
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/03/2019
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: 07/31/2019 Patient Sequence Number: 1
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