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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 482027
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Incontinence (1928); Injury (2348); Hematuria (2558)
Event Type  Injury  
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.
 
Manufacturer Narrative
Medtronic complaint report number: (b)(4). Additional information: exemption number: 2013003. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Per additional information received, pre-op diagnosis: ovulation bleeding, abnormal uterine bleeding, cervical polyps, and urethral diverticulum, and stress urinary incontinence. Dilation and curettage with hysteroscopy, cervical polypectomy, pubovaginal sling placement, urethral diverticulectomy, and cystoscopy. The patient has experienced stress urinary incontinence and required additional surgical interventions.
 
Manufacturer Narrative
Manufacturer reference number: (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 preoperative diagnosis was stress urinary incontinence. The procedure performed was a pubovaginal sling. On (b)(6) 2011 one or two episodes of stress incontinence occurred with a very full bladder. Hematuria was assessed. Urine cytology revealed presence of crystals. Between (b)(6) 2012 leakage worsened. Worsening stress incontinence and chronic microscopic hematuria was assessed. Sphincter deficiency was also assessed. The patient was scheduled for a cystoscopy and coaptite injection. The patient underwent an additional procedure on (b)(6) 2012. The preoperative diagnosis was stress urinary incontinence and intrinsic sphincter deficiency. The procedure performed was a cystoscopy and a coaptite injection.
 
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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
sharon murphy
15 hampshire street
mansfield, MA 02048
2034925267
MDR Report Key6344342
MDR Text Key248251263
Report Number9617613-2017-05006
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K992556
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup
Report Date 12/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/25/2013
Device Model Number482027
Device Catalogue Number482027
Device Lot Number09B20-9
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 Received11/15/2017
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 Initial

Patient Treatment Data
Date Received: 02/20/2017 Patient Sequence Number: 1
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