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

Model Number 5196001400

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

Patient Problems Pain (1994); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Hematuria (2558); Dysuria (2684); Constipation (3274); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521)

Event Type  Injury  

Manufacturer Narrative

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.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, legal representative stated serious and life altering injuries requiring extensive and invasive treatment for these injuries and removal of the novasilk.

Event Description

Additional information received further reported the patient experienced 1-centimeter of mesh erosion with braided permanent suture at the vaginal cuff, tenderness at the exposed area, dyspareunia, vaginal discharge, dysfunctional voiding pattern, frequency, nocturia, painful urination, blood in urine, constipation, tenderness over bilateral levators, and levator spasms which were noted prior to revision surgery.The patient was referred to physical therapy.

Manufacturer Narrative

D4 lot number: ak080055.

• Brand Name: UNKNOWN
• Type of Device: NOVASILK 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: 12603109
• MDR Text Key: 276104929
• Report Number: 2125050-2021-01467
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/03/2022

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5196001400
• Device Catalogue Number: 519600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2021
• Initial Date FDA Received: 10/11/2021
• Supplement Dates Manufacturer Received: 01/29/2022
• Supplement Dates FDA Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female