MAUDE Adverse Event Report:; SURGICAL MESH

Lot Number 5719609-0405

Device Problem Insufficient Information (3190)

Patient Problems Erosion (1750); Foreign Body Reaction (1868); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Injury (2348); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

This event was initial reported on (b)(6) 2016 on alternative summary reporting - exemption number (b)(4).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, patient's legal representative stated according to the available information the patient's legal representative stated vaginal odor, uti symptoms.Aris was implanted on (b)(6) 2007 and remains implanted.Additional information was received stating the patient suffered serious bodily injuries, including but not limited to foreign body reaction, urinary problems, dyspareunia, pelvic pain, vaginal pain, groin pain, leg pain, urinary tract infections, and other injuries.This event was initial reported on (b)(6) 2016 on alternative summary reporting - exemption number (b)(4).

Event Description

Additional information received on 8/8/2023 as follows: patient experienced voiding dysfunction, vaginal extrusion of mesh, and bothersome anterior vaginal prolapse.Vaginal exploration with partial removal of tot, vaginal reconstruction under general anesthesia was performed.

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release.No trends were noted for complaints and there were no nonconforming reports or capas that were confirmed to be associated.This complaint was investigated to the extent information was provided to coloplast.Due to the legal nature of this complaint and the device not being returned for evaluation a thorough investigation could not be executed.Should additional information become available, this file will be re-evaluated and updated according to current procedures.Complaints of this nature are monitored and captured within the product risk documentation.No further action or corrective action is required at this time.

Manufacturer Narrative

Correction: lot number updated from 5719509-040 to 5719609-045.Lot history search update: the lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release.No trends were noted for complaints and there were no nonconforming reports or capas that were confirmed to be associated.

• Type of Device: SURGICAL MESH
• Manufacturer Contact: brian schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 6128651177
• MDR Report Key: 9241425
• MDR Text Key: 163890481
• Report Number: 2125050-2019-00922
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: 5719609-0405
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Female