MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE DIRECT FIX A LOT NUMBER:; SURGICAL MESH

Model Number 5013601400

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Adhesion(s) (1695); Nausea (1970); Pain (1994); Scarring (2061); Urinary Tract Infection (2120); Prolapse (2475); Hematuria (2558)

Event Date 12/13/2010

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported to coloplast, though not verified, the patient's legal representative stated prolapse, documentation of poor support of anterior restorelle y secondary due to difficulty with placement secondary to prior adhesions, tight banding from midline anterior vaginal wall to posterior vaginal wall, multiple lines of vaginal scarring anterior/posterior, unable to perform adl's/exercise/sleep secondary to pelvic pain/pressure, right inguinal, pain with bowel movements, dyspareunia with nausea, unable to engage in physical activity secondary to chronic pelvic pain, perineal pain with neuropathic features, vaginal heaviness, and multiple uti's with hematuria.

• Brand Name: RESTORELLE DIRECT FIX A LOT NUMBER:
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 5981813
• MDR Text Key: 55789293
• Report Number: 2125050-2016-00231
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K103568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial
• Report Date: 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 5013601400
• Device Catalogue Number: 5013601400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR