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

Model Number 5196501022

Device Problem Insufficient Information (3190)

Patient Problems Irritation (1941); Pain (1994)

Event Date 12/09/2015

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 available information, a (b)(6) patient experienced nerve obturator irritation after altis procedure.Date of procedure: (b)(6) 2015.Date of onset event: (b)(6) 2015.Description of the event: nerve obturator irritation (pain type electric shock, eva=8) on left thigh.After osteopathy sessions, on (b)(6) 2016, pain decreased but it still provoked by effort.From (b)(6) 2017, patient had one time pain.Treatment: osteopathy (1 session/month).Status of the event: on (b)(6) 2018, pain much improved and is disappearing.

Manufacturer Narrative

This follow-up mdr is created to document the conclusion of the evaluation and the additional event information.The device remains implanted.Without the benefit of analyzing the explant, quality cannot confirm any observations and cannot comment on the condition of the device.Quality was not able to perform manufacturing record review, nonconforming report review, capa review or complaint database review due to the lot number not being provided.The most likely root cause of the event cannot be determined at this time.If the device or additional information is received, quality will re-evaluate this event in accordance with procedures.This complaint was forwarded to the contract manufacturer (cm) for review.The cm was not able to confirm the complaint or investigate further due to the lot number not being provided.

Event Description

Additional information recieved stated on (b)(6) 2018 the patient no longer reported pain.Exact date of resolution is not known.

• 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 rivier road north; minneapolis MN 55411
• Manufacturer Contact: sarah o'gara ; 1601 west rivier road north; minneapolis, MN 55411 ; 6123578517
• MDR Report Key: 7762026
• MDR Text Key: 116398129
• Report Number: 2125050-2018-00590
• 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,health professional,s
• Type of Report: Initial,Followup
• Report Date: 06/25/2019

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: 5196501022
• Device Catalogue Number: 519650
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/18/2016
• Initial Date FDA Received: 08/08/2018
• Supplement Dates Manufacturer Received: 11/18/2016
• Supplement Dates FDA Received: 06/26/2019
• 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
• Patient Age: 51 YR
• Patient Weight: 84