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

Model Number 5196501022

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 09/01/2017

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.Once our evaluation is complete, a follow-up report will be submitted.

Event Description

According to the available information, a (b)(6) patient experienced sling migration after altis procedure.Date of procedure: (b)(6) 2016; date of onset event: (b)(6) 2017; description of the event: sling migration in proximal.Treatment: revision of altis (section of the part that has migrated) and new surgical procedure (retropubic tvt) on (b)(6) 2018.Status of the event: resolved on (b)(6) 2018.According the investigator, the event is related to the procedure.

Manufacturer Narrative

This follow-up mdr is created to document the conclusion of the investigation.Quality was unsuccessful in securing the revised device for evaluation.Without the benefit of analyzing the device, quality cannot confirm any observations and cannot comment on the condition of the device.If the device becomes available, or additional information is received, quality will re-evaluate this complaint in accordance to procedures.However, because quality's examination may not conclusively confirm or disprove the report of migration, quality 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.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 4985236.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 information no further corrective action is required at this time.

Event Description

Additional information received stated, improved sui but persistent with semi-mobile urethra.

Manufacturer Narrative

This follow-up mdr is created to document the additional information received.

• Brand Name: ALTIS KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7749478
• MDR Text Key: 116039794
• Report Number: 2125050-2018-00580
• 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,Followup
• Report Date: 11/15/2018

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: Health Professional
• Device Model Number: 5196501022
• Device Catalogue Number: 519650
• Device Lot Number: 4985236
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/27/2018
• Initial Date FDA Received: 08/03/2018
• Supplement Dates Manufacturer Received: 04/27/2018; 04/27/2018
• Supplement Dates FDA Received: 09/26/2018; 11/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 67