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

Model Number 5014201400

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Pain (1994); Dysuria (2684); Dyspareunia (4505); Fecal Incontinence (4571); Urinary Incontinence (4572)

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

As reported to coloplast, though not verified, the patient with this device experienced dysuria, odorous urine, and was treated for urinary tract infections but continues to have pelvic pressure, abdominal pain persistent urinary incontinence, urinary frequency, dysuria, intermittent vaginal pain, dyspareunia.Extrusion of the surgical mesh was observed and was palpable.The following were also observed anterior vaginal scarring from sling, decreased anal sphincter tone, full incontinence of feces.In-office perineal/endovaginal/endoanal imaging was performed and a thin band of restorelle y comes down to urethrovesical angle with 90 degree anal sphincter defect, severe levator ani/anal sphincter muscle deficiency with long-standing fecal incontinence.The patient had 2 surgical mesh slings implanted at that time, one seen distal and is roped shaped, one seen cephalad (anterior) and highly convoluted (coiled).

• Brand Name: RESTORELLE Y
• 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: 12220288
• MDR Text Key: 263397007
• Report Number: 2125050-2021-00965
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• PMA/PMN Number: K112322
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5014201400
• Device Catalogue Number: 501420
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/24/2021
• Initial Date FDA Received: 07/23/2021
• 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