MAUDE Adverse Event Report: COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; SURGICAL MESH

Model Number 5196502400

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2019

Event Type  malfunction  

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, medwatch - mw (b)(4): dart broke loose and did not stay on the sling for implantation.Surgery for anterior repair, cystourethroscopy, sling.

Manufacturer Narrative

Based on the available information, the reported complaint is identified in the risk management documentation and reviewed routinely with management to monitor complaint trends as part of post market surveillance.No corrective action is required at this time.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

This follow-up mdr is created to document the additional event information received for record # (b)(4).According to the available information the altis sling was to be implanted in (b)(6) 2019; however, the information received indicated that the ¿dart broke loose and did not stay on the sling for implantation.¿ surgery was for anterior repair, cystourethyoscopy, and sling.No product was received for evaluation.Without examination of the product, quality cannot confirm the complaint as reported.A review of the device history record by the contract manufacturer confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, non-conformances and capas revealed no trends for this lot.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 10611162
• MDR Text Key: 209586148
• Report Number: 2125050-2020-00909
• 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: other
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5196502400
• Device Lot Number: 6848305
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/01/2020
• Patient Sequence Number: 1