MAUDE Adverse Event Report: COLOPLAST A/S ARIS TRANS-OBTURATOR KIT; SURGICAL MESH

Model Number 5195512400

Device Problem Insufficient Information (3190)

Patient Problems Erosion (1750); Foreign Body Reaction (1868); Micturition Urgency (1871); Incontinence (1928); Pain (1994); Hematuria (2558); Blood Loss (2597); No Information (3190); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

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 patient's legal representative stated serious bodily injuries, including but not limited to, foreign body reaction, erosion, vaginal bleeding, dyspareunia, vaginal pain, urinary incontinence and other injuries.

Manufacturer Narrative

This follow-up mdr is created to document the additional event and lot information received.The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

A partial excision of the mesh occurred on (b)(6) 2018.The mesh was removed on (b)(6) 2019.

Manufacturer Narrative

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

Event Description

Additional event information recieved stated, pt was diagnosed with stress incontinence and having mesh removed.She complained of vaginal bleeding, post menopausal bleeding, and erosion of bladder suspension mesh.

Manufacturer Narrative

H6 code e2402 applied to capture "possible localized ileus." coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

Additional information received further reported that in (b)(6) 2017, the patient was experiencing or had experienced post operative abdominal pain.X-ray revealed possible localized ileus.In (b)(6) 2018, the patient had experienced vaginal spotting for four months.The right-side of the sling was palpable.Small erosion was noted on the right side of the urethra.In (b)(6) 2019, the patient had experienced vaginal bleeding for two months.In (b)(6) 2019, the patient was experiencing or had experienced urinary incontinence and dyspareunia.Erosion was noted on the left side, with gross hematuria.In (b)(6) 2019, the patient was having issues with urinating.In (b)(6) 2020, the patient was experiencing or had experienced worsening of stress and urge incontinence.Plan for cystoscopy and coaptite injections.In (b)(6) 2020, the patient was experiencing or had experienced urinary incontinence secondary to intrinsic sphincter disorder and hypermobile urethra.Cystoscopy and coaptite injections took place under general anesthesia.In (b)(6) 2020, the patient was experiencing or had experienced urinary urgency.In (b)(6) 2020, incontinence and urgency continued.In (b)(6) 2020, urinary leakage continued.

• Brand Name: ARIS TRANS-OBTURATOR 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 rivier road north; minneapolis MN 55411
• Manufacturer Contact: brian schmidt ; 1601 west river road north; minnesota, MN 55411 ; 6128651177
• MDR Report Key: 8755364
• MDR Text Key: 149854573
• Report Number: 2125050-2019-00542
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 05708932442961
• UDI-Public: 05708932442961
• 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,Followup,Followup
• Report Date: 09/12/2022

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: 5195512400
• Device Catalogue Number: 519551
• Device Lot Number: 5378027
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2019
• Initial Date FDA Received: 07/02/2019
• Supplement Dates Manufacturer Received: 06/04/2019; 06/04/2019; 11/16/2020
• Supplement Dates FDA Received: 01/30/2020; 06/01/2020; 09/12/2022
• 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): Other
• Patient Age: 51 YR
• Patient Sex: Female