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

Model Number 5194001400

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Micturition Urgency (1871); Urinary Tract Infection (2120); Burning Sensation (2146); Urinary Frequency (2275); Prolapse (2475); Dyspareunia (4505); Skin Inflammation/ Irritation (4545)

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 with this device experienced severe vaginal irritation and burning, vaginal enterocele, atrophy, cystocele, rectocele, urinary urge incontinence, dyspareunia, vaginal vault prolapse, mesh exposure.Mesh removed on or about (b)(6) 2019.

Manufacturer Narrative

D4 lot number: 1031.Additional review determined this complaint is regarding t-sling mesh.The contract manufacturer is responsible for the assessment of reportability and submission of regulatory reports, as applicable.Manufacturer report number 2125050-2021-00863 was submitted by coloplast in error.

Event Description

Additional information received further reported the patient also experienced: urinary tract infections, overactive bladder symptoms beginning after implant, urinary frequency, and nocturia.Pelvic floor physical therapy helped; however, the patient was still unable to hold urine as long as she was able to prior to implant.The patient's vaginal burning sensation improved, but had not completely resolved.The patient stopped fluid intake by 6:00pm which improved her nocturia.

• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 12122999
• MDR Text Key: 260214631
• Report Number: 2125050-2021-00863
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/18/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 5194001400
• Device Catalogue Number: 519400
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/14/2021
• Initial Date FDA Received: 07/06/2021
• Supplement Dates Manufacturer Received: 09/13/2021
• Supplement Dates FDA Received: 02/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female