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

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.

• Brand Name: UNKNOWN PELVICOL PRODUCT
• 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 avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6415738
• MDR Text Key: 246431213
• Report Number: 9617613-2017-05041
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992556
• Number of Events Reported: 1
• 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 Received: 03/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: UNK PELVICOL
• Device Catalogue Number: UNK 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 Received: 02/15/2017
• 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