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

Model Number 5195511400

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Foreign Body Reaction (1868); Micturition Urgency (1871); Pain (1994); Scar Tissue (2060); Burning Sensation (2146); Urinary Frequency (2275); Dyspareunia (4505)

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 with this device experienced pain in hip, lower back, groin, thigh, knee and vagina.Heaviness in the lower abdomen and blockage in the right groin at recovery with tugging sensation the entire length of the right leg while standing.Subsequently, the patient felt vaginal pain, dyspareunia, muscular groin pain, leg pain, foreign material in vagina, urethral scarring.Therefore, mesh excision, urethral lysis, anterior colporrhaphy under general anesthesia was performed.

Manufacturer Narrative

D4 lot number: af010012.Additional review determined portions of this event were also reported under manufacturer report number 2125050-2021-01200.The complaints have been merged, and any further information will be submitted under this manufacturer report number, 2125050-2021-00924.

• 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: 12180800
• MDR Text Key: 261939010
• Report Number: 2125050-2021-00924
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K050148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2021

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?: Yes
• Device Model Number: 5195511400
• Device Catalogue Number: 519551
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/19/2021
• Initial Date FDA Received: 07/16/2021
• Supplement Dates Manufacturer Received: 11/15/2021
• Supplement Dates FDA Received: 11/16/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female