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

Model Number UR31053022

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure to Anastomose (1028); Abdominal Pain (1685); Erosion (1750); Diarrhea (1811); Fatigue (1849); Micturition Urgency (1871); Menstrual Irregularities (1959); Nausea (1970); Urinary Tract Infection (2120); Hot Flashes/Flushes (2153); Anxiety (2328); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Kidney Infection (4502); Dyspareunia (4505); Sexual Dysfunction (4510); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported to coloplast, though not verified, the patient underwent transobturator tape (tot) insertion and cystoscopy on (b)(6) 2018.The patient went back to the facility on (b)(6) 2020 with severe abdominal pain on a background history to tot.There were no signs of infection and she was discharged.The patient was placed on the waiting list for an urgent excision of the part of the mesh which had been protruding the wall of her vagina, and for repair of the vagina.Repair surgery was ultimately carried out at the same hospital on (b)(6) 2020.The surgery involved excising the part of the mesh that was protruding and repairing the vaginal wall.The rest of the mesh was left in situ.Post-repair surgery, the patient was informed by the treating team at the facility that the ¿mesh never worked, it was very loose and never attached to muscle at the time of insertion.¿.

Event Description

Additional information received further reported that the patient experienced a urinary tract infection in (b)(6) 2018.By (b)(6) 2019, the patient was suffering regular severe infections and occasionally found herself bedbound.The patient also experienced dyspareunia and loss of libido.An abdominal ultrasound in (b)(6) 2020 reported no pathological finding.Between (b)(6) 2020 and (b)(6) 2020, the patient attended her physician's office 17 times reporting abdominal pain, nausea, cramps and urinary tract infections.On exam, the patient had exposed mesh, which had eroded through the vaginal wall.The assessing doctor also noted the mesh to be loose suburethrally.The patient was also experienced kidney infection, apareunia, and had trouble walking.The patient was prescribed pain killers, and experienced a panic attack when she felt the mesh protruding inside her vagina.The patient was then prescribed xanax; she was nauseated due to the amount of medication she was taking.Her menstrual cycle had stopped, she was exhausted, had difficulty sleeping, and experienced hot flushes.

Manufacturer Narrative

Medical records were received and are being reviewed; any applicable details pertaining to the complaint will be submitted on a follow-up report once review is complete.

Event Description

Additional information obtained on 03/07/2023- medical review of the patient records noted that the patient also experienced weight loss over 3-4 months, diarrhea, urinary frequency and incontinence.

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.

• 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: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 11372596
• MDR Text Key: 233295450
• Report Number: 2125050-2021-00165
• 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,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/14/2023

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: Lay User/Patient
• Device Expiration Date: 09/30/2022
• Device Model Number: UR31053022
• Device Catalogue Number: UR3105
• Device Lot Number: 6184644
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 07/22/2022; 02/02/2023; 03/07/2023
• Supplement Dates FDA Received: 08/17/2022; 03/01/2023; 03/14/2023
• Date Device Manufactured: 03/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 57 KG