MAUDE Adverse Event Report: ALTUS ATHLETIC MANUFACTURING, INC. ALTUS EXERCISE BALL

Device Problem Burst Container or Vessel (1074)

Patient Problem Fall (1848)

Event Date 06/16/2016

Event Type  malfunction  

Event Description

Woman in labor sitting on altus exercise ball which suddenly burst, causing her so fall backwards hitting head and sacrum.

• Brand Name: ALTUS EXERCISE BALL
• Type of Device: ALTUS EXERCISE BALL
• Manufacturer (Section D): ALTUS ATHLETIC MANUFACTURING, INC. ; altus OK 73522
• MDR Report Key: 5748338
• MDR Text Key: 48346615
• Report Number: MW5063006
• Device Sequence Number: 1
• Product Code: ION
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2017
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 59