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); Inflammation (1932); Pain (1994); Urinary Frequency (2275); Injury (2348); Fungal Infection (2419); Prolapse (2475)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Incident date was not provided.Lot number not provided.Udi not provided.Re-processing information not provided.Device manufacture date: since the lot number was not provided, this information cannot be determined.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 and postoperative diagnosis was vaginal outlet relaxation and stress urinary incontinence.The procedure performed was a vaginal sling procedure for incontinence, cystoscopy, and percutaneous suprapubic cystotomy.At the same time an additional procedure was performed for vaginal vault prolapse and urinary incontinence.The procedure performed was an anterior colporrhaphy, posterior colporrhaphy, enterocele repair, and sling procedure.Approximately 2 weeks post op the patient had an office visit and was experiencing nocturia.The assessment was yeast vaginitis and was prescribed diflucan.Approximately 6 years and 5 months post op the patient stated she had some trouble emptying.She stated that when the bladder was out and she voided it would hurt.She experienced nocturia.She voids about every hour during the day.She stated when she has the urge she had to rush to the bathroom.There was minimal stress incontinence.She was assessed with bladder prolapse, atrophic vaginitis, bladder dysfunction, frequency, and nocturia.

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.

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.

• 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 avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6454042
• MDR Text Key: 71529276
• Report Number: 9617613-2017-05049
• 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,Followup
• Report Date: 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• 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
• Date Manufacturer Received: 03/15/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other