MAUDE Adverse Event Report: OTTO BOCK HEALTHCARE LP HARMONY® P3, SERVICE TEST CASE; VALVE, PROSTHESIS

Model Number 4R147=S

Device Problems Loose or Intermittent Connection (1371); Improper or Incorrect Procedure or Method (2017)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 04/22/2016

Event Type  No Answer Provided  

Event Description

This event occurred overseas in (b)(6) and has been translated accordingly per our affiliates in europe: a loaner system was provided to the customer in order to fit the patient with so that the patient was not immobilized during his/her repairs.Per the provided loaner kit, multiple functional rings are provided in order to allow the customer to choose the most appropriate fitting for the patient based on stiffness.The customer did not follow the provided instructions and ifu and did not appropriately tighten the functional ring to the pump system which is a requirement as specified in the instructions for use.The patient was using the product and while in use the functional ring became detached from the pump system and the patient fell to the ground.According to the initial reporter, the fall caused the patient to fracture his/her shoulder.Follow-up with regard to the health of the patient has been ongoing.At this point, multiple attempts to gain the additional information related to age, weight, height, patient sex and overall event details have been requested.All of this information has been documented in the record.

• Brand Name: HARMONY® P3, SERVICE TEST CASE
• Type of Device: VALVE, PROSTHESIS
• Manufacturer (Section D): OTTO BOCK HEALTHCARE LP; 3820 west great lakes drive; salt lake city UT 84120
• Manufacturer (Section G): OTTO BOCK HEALTHCARE LP; 3820 west great lakes drive; salt lake city UT 84120
• Manufacturer Contact: caleb beck ; 3820 west great lakes drive; salt lake city, UT 84120 ; 8019746647
• MDR Report Key: 5806159
• MDR Text Key: 49944486
• Report Number: 1721652-2016-00002
• Device Sequence Number: 1
• Product Code: ISP
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2016

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: Patient Family Member or Friend
• Device Model Number: 4R147=S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/24/2016
• Initial Date FDA Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1