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

Model Number UNK PELVICOL

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Micturition Urgency (1871); Incontinence (1928); Urinary Frequency (2275)

Event Type  Injury  

Manufacturer Narrative

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.Product was used for therapeutic treatment.Reason for surgery: stress urinary incontinence, small cystocele and urgency incontinence alleged complications post device implant include urinary incontinence, both stress and urge and urgency, small cystocele, overactive bladder.Surgery: (b)(6)2010: underwent coaptation of the urethra and cystoscopy for stress urinary incontinence and urgency incontinence under general anesthesia.Surgery: (b)(6)2011: urethral bulking with coaptite and contigen, cystoscopy for stress urinary incontinence and urge urinary incontinence under general anesthesia.Surgery: (b)(6)2016: underwent cystoscopy with retrograde pyelograms and hydrodistention of the bladder for overactive bladder and urinary incontinence under general anesthesia.

• Brand Name: PELVICOL
• Type of Device: MESH, 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 ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6714093
• MDR Text Key: 80052044
• Report Number: 9617613-2017-05105
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK PELVICOL
• Device Catalogue Number: UNK PELVICOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/06/2017
• Initial Date FDA Received: 07/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention