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

Model Number 5195512400

Device Problem Insufficient Information (3190)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Urinary Retention (2119); No Information (3190)

Event Date 02/19/2019

Event Type  Injury  

Manufacturer Narrative

The contract manufacturer reviewed the dhrs for (b)(4) and stated specifications were met.The lot number was reviewed by coloplast for complaint trend, nonconforming report and capa review.No trends were noted.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

According to the information provided by (b)(6), left and right groin pain (recently), right thigh, right knee goose leg, right hip and right buttock, low back pain, lumbar region, feeling of needles and razor blades in the area pelvic who cut me and feeling of sandpaper in the vagina heaviness in the vagina difficulty in urinating difficulty in walking difficulty in sitting for a long time or standing for a long time no more sexual intercourse or orgasm constant fatigue cerebral fog pain vaginal varices, bumps in the vagina and at the entrance of the vagina.

• 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 river road north; minneapolis MN 55411
• Manufacturer Contact: stephanie perryman ; 1601 west river road north; minneapolis, MN 55411 ; 6124345685
• MDR Report Key: 9287625
• MDR Text Key: 185200323
• Report Number: 2125050-2019-00939
• 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: foreign,other
• Type of Report: Initial
• Report Date: 11/06/2019

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 Lot Number: 6172787
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/07/2019
• Initial Date FDA Received: 11/06/2019
• 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