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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 UNK PELVICOL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Erosion (1750); Scarring (2061); Abnormal Vaginal Discharge (2123); Hernia (2240); Injury (2348); Prolapse (2475); Blood Loss (2597); Foreign Body In Patient (2687); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Incident date was not provided. Lot number not provided udi not provided. Re-processing information not provided. Device manufacture date: since the lot number was not provided, this information cannot be determined. (b)(4). A good faith effort will be made to obtain the applicable information relevant to the report. 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. Per additional information received, the patient has experienced pelvic organ prolapse, adhesions, umbilical hernia, blood loss, enterocele (prolapse), scarring/scar tissue, vaginal wall atrophy, oozing, clot, posterior defect, erosion, vaginal vault prolapse, vaginal discharge, foreign body in patient and additional surgical intervention.

 
Manufacturer Narrative

Corrected information: sex, date of birth, no eval explain code. If information is provided in the future, a supplemental report will be issued.

 
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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
sharon murphy
60 middletown avenue
north haven, CT 06473
2034925267
MDR Report Key6567950
MDR Text Key75192042
Report Number9617613-2017-05082
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 DISTRIBUTOR
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/17/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/15/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNK PELVICOL
Device Catalogue NumberUNK PELVICOL
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 Received04/17/2017
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 05/15/2017 Patient Sequence Number: 1
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