MAUDE Adverse Event Report: CRAMER PRODUCTS, INC. ACTIVE ANKLE VOLT; ANKLE BRACE

Model Number VOLT MEDIUM

Device Problem Fracture (1260)

Patient Problem Sprain (2083)

Event Date 03/09/2014

Event Type  Injury  

Manufacturer Narrative

Historical review of cramer product complaints for retroactive mdr reporting identified complaint as mdr reportable.Product not returned.

Event Description

Subject was playing in a volleyball tournament and had a collision with another player and the brace broke.During the collision, she rolled her ankle resulting in a 2nd degree sprain, front and back, involving two ankle ligaments.

• Brand Name: ACTIVE ANKLE VOLT
• Type of Device: ANKLE BRACE
• Manufacturer (Section D): CRAMER PRODUCTS, INC.; 153 west warren st; gardner KS 66030 1151
• Manufacturer (Section G): CRAMER PRODUCTS, INC.; 153 west warren st; gardner KS 66030 1151
• Manufacturer Contact: lisa piero ; 153 west warren st; gardner, KS 66030-1151 ; 9138567511
• MDR Report Key: 5510758
• MDR Text Key: 40685178
• Report Number: 1910082-2016-00001
• Device Sequence Number: 1
• Product Code: ITW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient Family Member or Friend
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: VOLT MEDIUM
• Device Catalogue Number: 760151
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 16 YR
• Patient Weight: 59