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

Model Number 5195512400

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Skin Erosion (2075); Genital Bleeding (4507)

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

As reported to coloplast, though not verified, between (b)(6) 2017- (b)(6) 2018: a pink vaginal discharge with foul odor, rough surface palpable vaginally, positive ua, possible vaginal erosion laterally on the right.Partially extruded 2-3 mm sling material.Operative report on (b)(6) 2017: partial excision sling, cystoscopy under unknown anesthesia, slight spotting, vaginal bleeding after intercourse, possible slight erosion, sui, blood per vagina during intercourse, partial erosion of sling, operative report: partial excision sling, cystoscopy under unknown anesthesia, 0.5 mm sling material excised.No other adverse patient effects were reported.

Event Description

As reported to coloplast, though not verified, between 11/8/2017-5/7/2018: a pink vaginal discharge with foul odor, rough surface palpable vaginally, positive ua, possible vaginal erosion laterally on the right.Partially extruded 2-3 mm sling material.Operative report on (b)(6) 2017: partial excision sling, cystoscopy under unknown anesthesia, slight spotting, vaginal bleeding after intercourse, possible slight erosion, sui, blood per vagina during intercourse, partial erosion of sling, operative report: partial excision sling, cystoscopy under unknown anesthesia, 0.5 mm sling material excised.No other adverse patient effects were reported.

Manufacturer Narrative

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.

• Brand Name: ARIS TRANSOBTURATOR KIT
• 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: 13015094
• MDR Text Key: 285969235
• Report Number: 2125050-2021-01791
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 05708932442961
• UDI-Public: 05708932442961
• Combination Product (y/n): N
• PMA/PMN Number: K050148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5195512400
• Device Catalogue Number: 519551
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/29/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Female