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 Pain (1994); Dysuria (2684)

Event Date 01/05/2016

Event Type  Injury  

Manufacturer Narrative

Because the device remains implanted, no product was returned.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 pelvic - suprapubic pain & dysuria after altis procedure.Date of onset event: (b)(6) 2016.Description of the events: spontaneous intermittent pelvic - suprapubic pain with intensity=4, dysuria with voiding difficulties : delay in spontaneous voiding and pvr, spontaneous resolution and normal voiding.Follow-up.No urinary infection.Treatment : hospitalization or prolongation of existing prolongation status of the event : resolved on (b)(6) 2016.Last visit of the patient to the hospital/surgeon on (b)(6) 2016 (device still implanted).

Manufacturer Narrative

This follow-up mdr is created to document the additional patient information and device information received, and the conclusion of the investigation: the device remains implanted.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 suprapubic pain and dysuria with voiding difficulties, qa accepts the physician's observations.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

According to the available information, patient experienced pelvic - suprapubic pain & dysuria after altis procedure.Date of onset event: (b)(6) 2016.Description of the events: spontaneous intermittent pelvic - suprapubic pain with intensity=4, dysuria with voiding difficulties : delay in spontaneous voiding and pvr, spontaneous resolution and normal voiding.Follow-up.No urinary infection.Treatment: hospitalization or prolongation of existing prolongation status of the event: resolved on (b)(6) 2016.Visit of the patient to the hospital/surgeon on (b)(6) 2016 (device still implanted).Additional information received indicated on (b)(6) 2018 : a monitoring visit was performed by the clinical research associate.In addition this patient came back to the hospital on (b)(6) 2017: no pain was specified in the medical notes at this visit, no other adverse event.Device still implanted.

Manufacturer Narrative

This follow-up mdr was created to document the additional patient and event information.

Event Description

Additional information from the surgeon indicated the following: event 1 (already reported) pelvic - suprapubic pain & dysuria after altis procedure.Description of the event 1: dysuria with voiding difficulties (straining to void).Spontaneous resolution and normal voiding follow-up.No urinary infection.Treatment: hospitalization with intermittent drainage (1 day).Event 2 (new event reported): urinary retention (pvr = 470 cc).Date of onset vent 2: (b)(6) 2015.Treatment of event 2: prolongation of existing hospitalization with indwelling urinary drainage (foley catheter) during 1 day status of event 2: resolved.Date of resolution of event 2: (b)(6) 2015.According to the surgeon, event 2 is related to the procedure.Last visit of the patient to the surgeon on (b)(6) 2017: device still implanted.

• 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 rivier road north; minneapolis, MN 55411 ; 6124345685
• MDR Report Key: 6425545
• MDR Text Key: 70629806
• Report Number: 2125050-2017-00052
• 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,Followup
• Report Date: 06/20/2019

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: Physician
• Device Model Number: 5196501022
• Device Catalogue Number: 5196501022
• Device Lot Number: 4556133
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/27/2016
• Initial Date FDA Received: 03/22/2017
• Supplement Dates Manufacturer Received: 01/27/2016; 01/27/2016
• Supplement Dates FDA Received: 06/07/2018; 06/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 73 YR
• Patient Weight: 75