MAUDE Adverse Event Report: OTTO BOCK HEALTHCARE LP 6Y402; OTTO BOCK CUSTOM BK REPLACEMENT LINER

Model Number 6Y402

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2015

Event Type  malfunction  

Manufacturer Narrative

Recently otto bock healthcare performed a retrospective review for complaints across all products manufactured in (b)(4).During the review this malfunction was discovered and it was determined to be reportable based on the criteria outlined in 21 cfr 803.

Event Description

Customer reported that liner umbrella was separating from the distal end of the liner.No adverse event was reported by the customer or end-user as a result of this specified failure.As this specific failure has potential to cause serious injury, out of an abundance of caution this complaint will be reported as an mdr.

• Brand Name: 6Y402; OTTO BOCK CUSTOM BK REPLACEMENT LINER
• Type of Device: 6Y402; OTTO BOCK CUSTOM BK REPLACEMENT LINER
• Manufacturer (Section D): OTTO BOCK HEALTHCARE LP; 3820 west great lakes drive; west valley city UT 84120
• Manufacturer (Section G): OTTO BOCK HEALTHCARE LP; 3820 west great lakes drive; west valley city UT 84120
• Manufacturer Contact: stephen anderson ; 3820 west great lakes drive; salt lake city, UT 84120 ; 8014257213
• MDR Report Key: 6316156
• MDR Text Key: 67381314
• Report Number: 1721652-2017-00002
• Device Sequence Number: 1
• Product Code: ISS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6Y402
• Device Catalogue Number: 6Y402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1