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

Model Number 5196501022

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problem Urinary Retention (2119)

Event Date 10/10/2016

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 urinary retention.Date of onset event : (b)(6) 2016.Post void residual volume on (b)(6) 2016 = 600 ml treatment : prolongation of hospitalization - medication (nitrofurantoin 100 mg 2x and 1 tablet per day during 14 days) - intermittent urinary drainage.Revision of the sling on (b)(6) 2016 - other treatment (not specified).Status of the event : on going.Device still implanted in patient on (b)(6) 2016.

Manufacturer Narrative

This follow-up mdr is created to document the corrected information in outcomes attributed to adverse events and the additional event, device and patient information received and updated method codes.Without the benefit of analyzing the device, qa cannot confirm any observations and cannot comment on the condition of the prosthesis.If the device becomes available, or additional information is received, qa will re-evaluate this complaint in accordance to procedures.However, because qa's examination may not conclusively confirm or disprove the report of retention, qa accepts the physician's observations of such as the reason for surgical intervention.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.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.

Event Description

Additional information received indicated post-operative urinary retention, precision on treatment : prolongation of hospitalization (for observation) - medication nitrofurantoin 100 mg (1 tablet 2 times/day during 14 days) - intermittent urinary drainage (once day) - revision of the sling on (b)(6) 2016 - no other treatment, status : resolved on (b)(6) 2017.According to the surgeon this event is related to the procedure.

• 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: 6308789
• MDR Text Key: 66726008
• Report Number: 2125050-2017-00009
• 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
• Type of Report: Initial,Followup
• Report Date: 10/11/2018

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: 5019174
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/24/2016
• Initial Date FDA Received: 02/07/2017
• Supplement Dates Manufacturer Received: 11/24/2016
• Supplement Dates FDA Received: 10/30/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR