MAUDE Adverse Event Report: ETHICON INC. VYPRO II MESH UND/VIO 15X10CM; MESH, SURGICAL, POLYMERIC

Catalog Number PVM2N3

Device Problem Migration (4003)

Patient Problems Erosion (1750); Incontinence (1928); Nerve Damage (1979); Pain (1994); Urinary Tract Infection (2120); Not Applicable (3189)

Event Date 07/09/2004

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.

Event Description

Completion letter (b)(4) received from (b)(6) in relation to ethicon gyn.Mesh - abdominal hernia surgical mesh, composite-polymer.Model #: vypro ii.Batch #: pvm2n3.Lot #: rg8c1cb0.Date of implantation: (b)(6) 2004.Clinical event information: vaginal mesh - ethicon - complications including pain, inability to properly empty bladder, recurrent uti, recurrence of prolapse.Further surgery to treat prolapse - removal of uterus intended but not performed as mesh had invaded native tissue and surgeon would not attempt.Another mesh product inserted, but left me totally incontinent and nerve damage made bowel non-functioning.Patient was hospitalised to try to remedy incontinence caused from mesh insertion.Surgeon used another mesh product.Many consultations to neurologists and other medical specialist from that date to try to find a treatment for bowel damage.Finally admitted to hospital, for implant of neurostimulator.Ongoing and increasing pelvic pain.No further information available as reporter details have not been disclosed (confidential).

• Brand Name: VYPRO II MESH UND/VIO 15X10CM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; norderstedt ; GM
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8058390
• MDR Text Key: 126967370
• Report Number: 2210968-2018-77086
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K002672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PVM2N3
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention