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

Model Number 5014201400

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Erosion (1750); Micturition Urgency (1871); Hair Loss (1877); Pain (1994); Rash (2033); Urinary Tract Infection (2120); Numbness (2415); Fungal Infection (2419); Dysuria (2684); Constipation (3274); Paresthesia (4421); Dyspareunia (4505); Genital Bleeding (4507); Implant Pain (4561)

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.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 in addition to a competitor's device experienced pelvic, rectal, low back, vaginal, abdominal and upper thigh pain, rectal bleeding, dyspareunia, bleeding after intercourse, urinary tract infections, constipation, blood with bowel movement.A colonoscopy showed an anal fissure.Transvaginal urethrolysis, abdominal vaginal exploration of retropubic space was performed for mesh removal, lysis of adhesion, excision of sacrocolpopexy mesh, cervical hysterectomy, closure of vaginal cuff, and anterior vaginal wall reconstruction for complication of mesh.

Manufacturer Narrative

D4 lot number: 110318-01.

Event Description

Additional information received further reported that the patient also experienced: chronic yeast infections, rashes and hair loss, hispareunia (her husband's penis caught during intercourse), difficulty with urinary emptying, occasional dysuria, left leg pain with numbness and tingling, possible mesh exposure, superficial erosion into the posterior fornix, and urgency.

• 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: 12167779
• MDR Text Key: 261775802
• Report Number: 2125050-2021-00908
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/25/2022

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: Health Professional
• Device Model Number: 5014201400
• Device Catalogue Number: 501420
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2021
• Initial Date FDA Received: 07/14/2021
• Supplement Dates Manufacturer Received: 07/29/2021
• Supplement Dates FDA Received: 02/25/2022
• 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: 40 YR
• Patient Sex: Female