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

Model Number 5196502400

Device Problem Insufficient Information (3190)

Patient Problems Edema (1820); Incontinence (1928); Muscle Spasm(s) (1966); Pain (1994); Sleep Dysfunction (2517); Weight Changes (2607)

Event Date 12/01/2014

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.

Event Description

According to the information provided by health (b)(6), reflex algodystrophy right leg, edema of my right foot, mental exhaustion related to chronic pain.Pain: right groin, inner side right thigh up to the knee, the entire pelvis on the right, right iliac crest, right hip, the outer side of the right thigh, the entire right sacroiliac area (lower back) bilateral.Intermittent vaginal and / or anal spasm and psoas (stomach pain).Pond right side tilted forward and frozen, decreased my mobility.Stiffness in the legs, little lateral amplitude to lean on the side d (pelvis frozen).Prolonged painful sitting, increased pain right from the loading on my right leg (every step), bending or getting up is not always easy and easy.Getting off the car requires a precise way of doing things.Little comfortable position to sleep.Removing a shoe using the other foot triggers a sharp pain in the right hip.Decreased sexual pleasure.Pain during sexual activity.Incontinence on imperious desire.35lbs weight gain.

• Brand Name: ALTIS 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: 9287630
• MDR Text Key: 185186652
• Report Number: 2125050-2019-00943
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• PMA/PMN Number: K121562
• 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: 5196502400
• 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