MAUDE Adverse Event Report: OSSUR HF ICEROSS COMFORT; LINER

Model Number I-500626

Device Problem Misassembled During Installation (4049)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Event Description

The patient had been using the device for 5 months when he noticed that the locking pin had disconnected.He reattached the locking pin by hand and did not inform his cpo about the issue.A few days later the locking pin disconnected while he was walking.This caused the patient to fall, leaving him with a wound on the stump that required stitches.The patient will fully recover.

Manufacturer Narrative

Product failed when attachment pin came loose from umbrella.No indication of material or manufacturing issue.Issue likely due to failure to follow instructions in regards to correct torque and securement of attachment pin in umbrella as pin was not fitted with recommended loctite 410/411.The likelihood of this type of failure leading to a hazardous event resulting in a serious injury is considered negligible.Further actions are not considered warranted.

• Brand Name: ICEROSS COMFORT
• Type of Device: LINER
• Manufacturer (Section D): OSSUR HF; grjothals 1-5; reykjavik, 110 ; IC 110
• Manufacturer Contact: katla axelsdottir ; grjothals 1-5; reykjavik, ; IC
• MDR Report Key: 17142297
• MDR Text Key: 317299158
• Report Number: 3003764610-2023-00014
• Device Sequence Number: 1
• Product Code: ISS
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: I-500626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other