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U.S. Department of Health and Human Services

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

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TISSUE SCIENCE LABORATORIES UNKNOWN PELVICOL PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNK PELVICOL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Micturition Urgency (1871); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Injury (2348); Prolapse (2475); Hematuria (2558); Dysuria (2684); Constipation (3274)
Event Type  Injury  
Manufacturer Narrative

(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 resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. The patient returned for an office visit on (b)(6) 2004 for occasional dysuria, stress type urinary incontinence, and complained of chronic constipation. There was an irregularity palpated which appeared to be a stitch that was just submucosal from her previous surgery. The patient returned for an office visit on (b)(6) 2005 for bladder problems with cystocele, urethrocele and enterocele. The patient returned for an office visit on (b)(6) 05 for uti. The patient complained of bladder pressure sensation, urinary frequency, and burning on urination. She still had a uti. The patient returned for an office visit on (b)(6) 2006 for uti and interstitial cystitis. The patient returned for an office visit on (b)(6) 2007 for uti with occasional bloody discharge from vagina, some urgency and stress type urinary incontinence although the urge component for her was worse. After examination it was found that she had microscopic hematuria, erosion of the suspension material in the vagina and frequency/urgency. The patient returned for an office visit on (b)(6) 2007 for mild stress type urinary incontinence. The patient returned for an office visit on (b)(6) 2008. She was currently being treated for interstitial cystitis. She had flair-ups that come and go. She complained that she had symptoms of a uti. The patient returned for an office visit on (b)(6) 2008 for stress type urinary incontinence. The patient returned for an office visit on (b)(6) 2008 post aris sling placement on (b)(6) 2008 with mild urgency and uti. The patient returned for an office visit on (b)(6) 2008 for urgency/frequency and uti. The patient returned for an office visit on (b)(6) 2008 for pelvic pain and uti. The patient returned for an office visit on (b)(6) 2009 and complained of urgency and difficulty with control of urine. The patient returned for an office visit on (b)(6) 2009 for a cystoscopy. She had a previous sling. Her complaint was that she had infections and there is some question whether there was erosion. Visually there was no evidence of erosion noted. The patient returned for an office visit on (b)(6) 2010 for a uti, dysuria and ic. The patient returned for an office visit on (b)(6) 2011 for uti, frequency, urgency, and interstitial cystitis. The patient returned for an office visit on (b)(6) 2011 for interstitial cystitis. The patient returned for an office visit on (b)(6) 2012 for interstitial cystitis and uti along with frequency and urgency. The patient returned for an office visit on (b)(6) 2012 for uti. The patient returned for an office visit on (b)(6) 2012 for uti, chronic cystitis, and interstitial cystitis. The patient returned for an office visit on (b)(6) 2013 for uti, chronic cystitis and interstitial cystitis. The patient returned for an office visit on (b)(6) 2014 for chronic cystitis and interstitial cystitis. The patient returned on (b)(6) 2014 for chronic cystitis, interstitial cystitis and uti. The patient returned on (b)(6) 2015 for interstitial cystitis, trouble urinating, and frequency and burning sensation when she urinates.

 
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 NameUNKNOWN PELVICOL PRODUCT
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 Key6390074
MDR Text Key69438413
Report Number9617613-2017-05023
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 ATTORNEY
Type of Report Initial,Followup
Report Date 02/08/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/08/2017
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 Received02/08/2017
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: 03/08/2017 Patient Sequence Number: 1
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