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

Model Number 5166101400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Post Operative Wound Infection (2446); Genital Bleeding (4507)

Event Date 10/01/2015

Event Type  Injury  

Event Description

As reported to coloplast, though not verified, patient's legal representative stated pain, infection, worsened incontinence, urinary problems, dyspareunia, mesh erosion, vaginal bleeding.Additional information received on 04/09/2021.On (b)(6) 2015 - mesh erosion and recurrent sui.Pubovaginal sling with rectovaginal graft harvest and mesh excision.No other adverse patient effects were reported.

Manufacturer Narrative

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.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Device not returned.

Event Description

Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type relating to the reported complaints are captured in the product risk documentation.Based on this, and because the device is not available for evaluation, no further corrective action is required at this time.

Manufacturer Narrative

According to the available information, the patient's legal representative stated pain, infection, worsened incontinence, urinary problems, dyspareunia, mesh erosion, vaginal bleeding.Omnisure was implanted on (b)(6) 2012 and excised on (b)(6) 2015.Corrective action: management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type relating to the reported complaints are captured in the product risk documentation.Based on this, and because the device is not available for evaluation, no further corrective action is required at this time.

• Brand Name: OMNISURE
• 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: 13043677
• MDR Text Key: 282499945
• Report Number: 2125050-2021-01827
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K092203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5166101400
• Device Catalogue Number: 516610
• Device Lot Number: 2993972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Female