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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 482027
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Wound Dehiscence (1154); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Erosion (1750); Purulent Discharge (1812); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Perforation (2001); Urinary Tract Infection (2120); Urinary Frequency (2275); Prolapse (2475); Bowel Perforation (2668); Fluid Discharge (2686); Unspecified Tissue Injury (4559); Urinary Incontinence (4572)
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 implanted as a sling for therapeutic treatment of in continence and grade-3 cystocele. It was reported that after implant, the patient experienced perforated bowel, prolapse recurrence with large enterocele as well as cystocele, pain, erosion, extrusion, inflammation, abdomen abscess pocket, infection, unspecified urinary/bowel problems, dyspareunia, adhesions, abdomen/feculent material discharge, fascial dehiscence, fibrinous exudate material, stress urinary incontinence recurrence, blood loss, urinary tract infection, and urinary frequency. Post-operative patient treatment included exploratory laparotomy, small bowel resection, cystoscopy, sacral colpopexy, and implant of new mesh.

 
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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
UK GU11 1EJ
Manufacturer (Section G)
TISSUE SCIENCE LABORATORIES
victoria house, victoria road
aldershot, hampshire GU11 1EJ
UK GU11 1EJ
Manufacturer Contact
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key10868715
MDR Text Key217131164
Report Number9617613-2020-00082
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,Followup,Followup,Followup
Report Date 12/14/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/19/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/25/2004
Device MODEL Number482027
Device Catalogue Number482027
Device LOT Number02A19
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 Received11/25/2020
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: 11/19/2020 Patient Sequence Number: 1
Treatment
PRECISION TWIST TRANSVAGINAL ANCHOR SYSTEM
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