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

Model Number 5195511400

Device Problem Insufficient Information (3190)

Patient Problems Erosion (1750); Foreign Body Reaction (1868); Incontinence (1928); Unspecified Infection (1930); Muscle Spasm(s) (1966); Pain (1994); Pocket Erosion (2013); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Fungal Infection (2419); Hematuria (2558); Blood Loss (2597); No Information (3190)

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 oct-november 2017.This mdr is to reflect the additional information to be added to the initial asr report.(patient age and product information).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 october-november 2017.This mdr is to reflect the additional information to be added to the initial asr report.

Event Description

As reported to coloplast though not verified,additional information received stated erosion and infection were also noted.

Manufacturer Narrative

The follow-up was created to document the additional event informtion.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Manufacturer Narrative

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 stated, information stated on (b)(6) 2009 patient experienced stress incontinence, vaginal leukorrhea and candida vulvovaginitis, incontinence.Information stated between (b)(6) 2011- (b)(6) 2017 patient experienced uti, hematuria, vaginal bleeding, unspecified urinary incontinence, periurethral mesh erosion, vaginal infection, small erosion, urinary retention from bladder floor spasm, sui, erosion, vaginal mesh excision ((b)(6) 2017), cystoscopy, urethrolysis, wound debridement.The patient had an additional aris sling, reported under 2125050-2020-00095.Information did not specify which aris sling the events between 10/21/2011-3/30/2017 were reported for.

• Brand Name: ARIS TRANS-OBTURATOR KIT
• Type of Device: SURGICAL MESH
• MDR Report Key: 9714080
• MDR Text Key: 179704144
• Report Number: 2125050-2020-00151
• 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: 06/18/2020

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: 5195511400
• Device Catalogue Number: 519551
• Device Lot Number: 1731171
• 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: 04/30/2020; 06/18/2020
• Patient Sequence Number: 1
• Patient Age: 58 YR