MAUDE Adverse Event Report: COLOPLAST A/S ARIS TRANSOBTURATOR KIT; SURGICAL MESH

Model Number 5195501400

Device Problems Device Appears to Trigger Rejection (1524); Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Bacterial Infection (1735); Incontinence (1928); Inflammation (1932); Pain (1994); Pocket Erosion (2013); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Hematuria (2558); Blood Loss (2597); No Code Available (3191)

Event Date 11/02/2011

Event Type  Injury  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.(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, the legal representative stated there was a palpable rough spot on anterior vaginal wall, old suture was visualized, uti, vaginal discharge, roughness of vaginal mucosa left sidewall, vaginal foreign body, and bacterial vaginosis.(b)(6) 2014 - revision surgery.(b)(6) 2015 abdominal pain, suprapubic pain, uti, vaginal discharge, roughness of vaginal mucosa, malodorous vaginal discharge, vaginal bleeding, vaginal foreign body/mesh erosion, granulation tissue, visible retained suture in anterior vaginal wall.Back pain radiating down leg, vaginal spotting, ua + for uti, mesh lesion on exam, protrusion through anterior vaginal wall, vaginal open areas with minimal bleeding, urinary incontinence, occasional urge incontinence, occasional hematuria, nocturia, urinary frequency.(b)(6) 2017 - vaginal mesh erosion - large portion in left and right vaginal sulcus with attachment to midurethra, abnormal bleeding, discharge, pain.Revision.(b)(6) 2017 urethrolysis, excision of vaginal mesh and cystoscopy under general anesthesia.Pathology: chronic inflammation, bacterial forms are also present.

Event Description

Additional information received further reported that the patient also experienced retention and refractory overactive bladder.

Manufacturer Narrative

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

• Brand Name: ARIS TRANSOBTURATOR KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis, mn
• Manufacturer Contact: brian schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 6128651177
• MDR Report Key: 10222145
• MDR Text Key: 201196028
• Report Number: 2125050-2020-00470
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2022

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: Health Professional
• Device Model Number: 5195501400
• Device Catalogue Number: 519550
• Device Lot Number: 5726226
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/02/2020
• Initial Date FDA Received: 07/01/2020
• Supplement Dates Manufacturer Received: 07/25/2021
• Supplement Dates FDA Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 53 YR
• Patient Sex: Female