MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE DIRECTFIX; SURGICAL MESH

Model Number 5014502400

Device Problem Insufficient Information (3190)

Patient Problems Erosion (1750); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Scarring (2061); Injury (2348); Dysuria (2684); No Information (3190); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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, patient's legal representative stated patient suffered serious bodily injuries, including, but not limited to, foreign body reaction, chronic inflammation, excessive scarring, contraction, erosion, dysuria, bladder pain, pelvic pain, dyspareunia, and other injuries.

Event Description

Additional information received further reported that on (b)(6) 2017 the patient was experiencing or had experienced stabbing vaginal pain and a pulling sensation in her right groin, vaginal pressure, and clitoral pain.Mesh erosion occurred, approximately 1cm x 2cm on the right anterior wall approximately 4cm from introit.The patient also experienced myofascial tenderness, frequency due to suprapubic pressure and cramping, and often had to double void.

Manufacturer Narrative

H6 code e2402 applied to capture "a pulling sensation in her right groin, vaginal pressure." coloplast has not been provided any corroborating evidence to verify the information contained in this report.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

• Brand Name: RESTORELLE DIRECTFIX
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: brian schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 6128651177
• MDR Report Key: 9319524
• MDR Text Key: 166305498
• Report Number: 2125050-2019-01016
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5014502400
• Device Catalogue Number: 501450
• Device Lot Number: 5241593
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female