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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 482047
Device Problems Material Erosion (1214); Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Erosion (1750); Emotional Changes (1831); Fistula (1862); Low Blood Pressure/ Hypotension (1914); Incontinence (1928); Pain (1994); Scarring (2061); Discharge (2225); Distress (2329); Discomfort (2330); Injury (2348); Prolapse (2475); Blood Loss (2597); Bowel Perforation (2668); Alteration In Body Temperature (2682); No Code Available (3191); Constipation (3274)
Event Type  Injury  
Manufacturer Narrative

Previously reported as asr. Additional information:updates to relevant history, event description, patient weight, and all patient codes. 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 prolapse and stress urinary incontinence. It was reported that after implant, the patient experienced vaginal vault prolapse/cystocele, continuous pain, extrusion, unspecified urinary problems, unspecified bowel problems, fistulae, dyspareunia, vaginal scarring, blood loss, adhesions, nocturia, atrophy, postoperative bleeding, temperature, discomfort, drainage, mental and physical stress, damage to vaginal vault, bowel perforation, chronic constipation, hypotension, pelvic trauma, rectocele, and incontinence. The device had been used with microvasive des precision twist anchor sys. Post-operative patient treatment included numerous nonsurgical and additional surgical interventions as well as additional implant and duloxetine and gavaprin medications for nerve pain.

 
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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 Key8768102
MDR Text Key150387837
Report Number9617613-2019-00116
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK992556
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 07/08/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/08/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/11/2002
Device MODEL Number482047
Device Catalogue Number482047
Device LOT Number01A03
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/12/2019
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: 07/08/2019 Patient Sequence Number: 1
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