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

Model Number 5196501022

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Cyst(s) (1800); Unspecified Infection (1930); Inflammation (1932); Urinary Tract Infection (2120); Burning Sensation (2146)

Event Date 09/16/2015

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 of 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 patient experienced cystitis after altis procedure.Urinary tract infection without fever (undocumented urinary burns).Action/treatment : fosfomycin trometamol monodose.Resolved (b)(6) 2015.

Manufacturer Narrative

This follow-up mdr is created to document the conclusion of the evaluation with the addition of the lot number and updated codes.This complaint was forwarded to the contract manufacturer (cm) for review.The cm reviewed the manufacturing records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.Quality reviewed the manufacturing records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.A review of the complaint history database revealed no significant trends for lot 4359069.Review of nonconforming reports revealed no nonconformance's for this lot.No capas are associated with this lot.Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type are captured in the product risk documentation.Based on this, and because the device is not available for evaluation, no further corrective action is required at this time.

• Brand Name: ALTIS KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: sarah o'gara ; 1601 west rivier road north; minneapolis, MN 55411 ; 6123578517
• MDR Report Key: 6345701
• MDR Text Key: 67848434
• Report Number: 2125050-2017-00025
• 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,study
• Type of Report: Initial,Followup
• Report Date: 11/13/2018

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: Physician
• Device Model Number: 5196501022
• Device Catalogue Number: 5196501022
• Device Lot Number: 4359069
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/21/2015
• Initial Date FDA Received: 02/21/2017
• Supplement Dates Manufacturer Received: 09/21/2015
• Supplement Dates FDA Received: 11/14/2018
• 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: 44 YR