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

Model Number 5196502400

Device Problem Missing Information (4053)

Patient Problem Insufficient Information (4580)

Event Date 09/21/2020

Event Type  malfunction  

Manufacturer Narrative

The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.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, though not verified, reported complaint per clinical coordinator: "[the physician] did a case today there he implanted/explanted 2 of the altis slings.I wasn¿t in the room but he was having trouble with the slings." this is complaint 2 of 2.

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.

Event Description

According to the available information the date of the altis procedure was on (b)(6) 2020.Information received indicated: ¿[the physician] did a case today there he implanted / explanted 2 of the altis slings.I wasn't in the room but he was having trouble with the slings.¿ additional information received from the physician indicated: ¿i could not get it to anchor in the right obturator fascia / internus.It kept pulling out when we adjusted the sling.I tried two kits and then went to a [non-coloplast] fit.¿ no components were received for evaluation.Without the benefit of analyzing the components, quality cannot confirm any observations or comment on the condition of the product.If the components become available, or additional information is received, the complaint will be re-evaluated according to procedures.A review of the complaint history database revealed no trends for this lot.Review of nonconforming reports revealed no nonconformance¿s for this lot.No capas are associated with this lot.No patient injury was reported.Cm reviewed 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.

• 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: 10723538
• MDR Text Key: 214140362
• Report Number: 2125050-2020-00992
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 7154369
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2020
• Patient Sequence Number: 1