MAUDE Adverse Event Report: COLOPLAST A/S SUPRIS SUPRAPUBIC; SURGICAL MESH

Model Number 5195611400

Device Problem Extrusion (2934)

Patient Problems Erosion (1750); Hemorrhage/Bleeding (1888); Irritation (1941); Pain (1994); Tissue Damage (2104); Urinary Tract Infection (2120); Vaginal Mucosa Damage (2124); Burning Sensation (2146); Discomfort (2330); Intermenstrual Bleeding (2665); Dysuria (2684); Fluid Discharge (2686)

Event Date 01/23/2013

Event Type  Injury  

Event Description

As reported to coloplast though not verified, patient was implanted with supris suprapubic mesh.Later the patient experienced discomfort with sexual activity, tenderness to palpation, rectal bleeding, urinary tract infection, mild vaginal discomfort, vulvar irritation, some dysuria, dyspareunia, mild amount of sanguineous drainage, burning at the vaginal introitus with intercourse, pelvic floor pain, external pain with intercourse, tender area on posterior vaginal vault, postmenopausal bleeding with pelvic pain, spotting, discharge, bright red vaginal bleeding and mesh erosion.Urethrolysis and a removal of the mesh were performed.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

• Brand Name: SUPRIS SUPRAPUBIC
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtendam-1; humlebaek 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river rd. north; minneapolis MN 55411
• Manufacturer Contact: tim crabtree- mgr ; 1601 west river rd. north; minneapolis, MN 55411 ; 6122874164
• MDR Report Key: 3763620
• MDR Text Key: 19590914
• Report Number: 2125050-2014-00045
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K111233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Type of Report: Initial
• Report Date: 01/15/2014

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?: No
• Device Operator: Other
• Device Expiration Date: 09/30/2013
• Device Model Number: 5195611400
• Device Catalogue Number: 5195611400
• Device Lot Number: 1743704
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/08/2014
• Initial Date FDA Received: 01/15/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/30/2008
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other