MAUDE Adverse Event Report: ARIS TRANS-OBTURATOR SLING; SURGICAL MESH

Model Number 5195102400

Device Problem Insufficient Information (3190)

Patient Problems Fatigue (1849); Fever (1858); Foreign Body Reaction (1868); Micturition Urgency (1871); Incontinence (1928); Nausea (1970); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Vomiting (2144); Urinary Frequency (2275); Blood Loss (2597); Dysuria (2684); No Information (3190); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This mdr is created as a follow-up to record (b)(4), initially reported on product code otn asr exemption # e2014015 for april-may 2018.This mdr is to reflect the additional information to be added to the initial asr report.(patient age, product information, corrected implant date).The lot number was reviewed for complaint trend, nonconforming report and capa review.No trends were noted.

Event Description

This mdr is created as a follow-up to record (b)(4), initially reported on product code otn asr exemption # e2014015 for april-may 2018.This mdr is to reflect the additional information to be added to the initial asr report.

Manufacturer Narrative

This follow-up mdr is created to document the additional event information and explant date received.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

Additional information reported to coloplast, though not verified, indicated urinary retention.

Event Description

Additional information, reported to coloplast though not verified, indicated urinary retention, pain, fever, nausea, vomiting, fatigue, uti, hip pain, flank pain, trouble urinating, urinary frequency, urinary urgency, tenderness, right groin incision, vaginal pain, questionable blood clot in bladder, dysuria, uti, incomplete emptying, nocturia, incontinence, dyspareunia, bleeding after intercourse, urethra tender over sling, sui.(b)(6) 2017 - diagnostic cystoscopy, vaginal exploration with removal of the right arm of mid urethral sling, urethrolysis, and groin exploration under ga, passing blood clots.

Manufacturer Narrative

Patient code 3191 was selected due to an appropriate code not available for blood clot in bladder, nocturia.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

• Brand Name: ARIS TRANS-OBTURATOR SLING
• Type of Device: SURGICAL MESH
• MDR Report Key: 9713867
• MDR Text Key: 188851355
• Report Number: 2125050-2020-00098
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 5195102400
• Device Lot Number: 3264274 / AL090061
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/27/2020; 07/01/2020
• Patient Sequence Number: 1
• Patient Age: 57 YR