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

Model Number UNK PELVICOL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Micturition Urgency (1871); Incontinence (1928); Urinary Frequency (2275); Injury (2348); Prolapse (2475); No Code Available (3191)

Event Type  Injury  

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 preoperative and postoperative diagnosis was stage 3 pelvic organ prolapse with large cystocele and stress urinary incontinence.The procedure performed was an anterior colporrhaphy with mesh and a tension-free vaginal tape with mesh, and cystoscopy.The patient underwent an additional procedure approximately 3 years post op.The preoperative and postoperative diagnosis was vaginal vault prolapse with enterocele and rectocele.The procedure performed was an abdominal colposacropexy with mesh, posterior colporrhaphy, and cystoscopy.The patient underwent an additional procedure approximately 9 years post op.The preoperative and postoperative diagnosis was symptomatic rectocele and vaginal vault prolapse.The procedure performed was a bilateral sacrospinous ligament fixation and posterior colporrhaphy with xengraft.At this time a xenoform soft tissue repair mesh was implanted.The patient returned for an office visit for a postoperative visit.The patient was doing well but still had some minor urgency/frequency and rare urge incontinence.The patient returned for an office visit on approximately 12 years and 2 months post op for urinary incontinence.The previous sling appeared to be palpable and appeared to have migrated away from the mid urethral and over the urethrovesicle junction.It was not painful and there was not mesh erosion.The patient underwent an additional procedure approximately 12 years and 3 months pot op.The preoperative and postoperative diagnosis was recurrent stress urinary incontinence and recurrent rectocele.The procedure performed was a posterior colporrhaphy, excision of previous sling, and placement of obtryx halo sling and cystoscopy.At this time a boston scientific sling microvasive uphold obtryx transobturator halo was implanted.The patient returned for an office visit approximately 12 years and 4 months post op.The patient was still leaking.

Manufacturer Narrative

(b)(4).

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: 6600428
• MDR Text Key: 76245335
• Report Number: 9617613-2017-05087
• 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: distributor
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2017
• 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; Required Intervention