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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 Abdominal Pain (1685); Urinary Frequency (2275); Hematuria (2558)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
(b)(4).
 
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 reason for mesh implantation was pelvic prolapse and stress urinary incontinence. The procedure performed was a anterior colporrhaphy with sacrospinous ligament fixation and pubovaginal sling. Three days postop, the patient complained of some low back discomfort. She had some difficulty with bowel movements. She was assessed with post-operative discomfort. Approximately 2 weeks post op, the patient presented with mild vaginal bleeding and some minimal low back pain. Approximately 5 months post op the patient had some lower abdominal pain and some more urinary frequency. She had minimal urge incontinence. Her microhematuria was possibly related to uti. Approximately 1 year and 5 months post op she was having episodic stress and urge incontinence. She also had a uti in the last several months. She also had urethral hypermobility. She was assessed with mixed urinary incontinence status post-accident after pelvic floor reconstruction and probable acute uti. Approximately 1 year and 6 months the patient had recurrent urinary incontinence over the last 6 to 12 months. She leaked with coughing, sneezing, and with urgency. She was assessed with high pressure voiding with poorly compliant bladder, detrusor overactivity, and evidence of urethral obstruction as indicated by high pressure voiding. Approximately 1 year and 6 months post op, the patient had some evidence of detrusor overactivity during filling and with voiding during urodynamic study. She was assessed with lower urinary dysfunction secondary to probably urethral obstruction status post pelvic floor reconstruction, detrusor overactivity secondary to above with good emptying actually, and microhematuria. The patient underwent an additional procedure for urethral obstruction status post pelvic floor reconstruction. The procedure performed was a urethral dilation, cystoscopy, and bilateral retrograde pyelogram. In 2006, the patient underwent an additional procedure for vaginal prolapse, incontinence, and difficulty voiding. The procedure performed was an urethrolysis, sling, anterior repair, and sacrospinous fixation with graft.
 
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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 Key6415738
MDR Text Key246431213
Report Number9617613-2017-05041
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
Report Date 02/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received02/15/2017
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 Unkown

Patient Treatment Data
Date Received: 03/17/2017 Patient Sequence Number: 1
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