MAUDE Adverse Event Report: CRAMER PRODUCTS, INC. ACTIVE ANKLE T2; ANKLE BRACE

Model Number T2

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Bruise/Contusion (1754); Damage to Ligament(s) (1952); Sprain (2083)

Event Date 09/04/2013

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

Complainant states that on (b)(6) 2013 her daughter was injured practicing volleyball.She jumped and landed on top of someone else's foot then fell to the floor while wearing two t2 braces.The braces did not break, however, her daughter was diagnosed with grade 3 sprain, bone bruise, and a torn ligament.

• Brand Name: ACTIVE ANKLE T2
• 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 ; 9138567511
• MDR Report Key: 5510503
• MDR Text Key: 40675086
• Report Number: 1910082-2016-00003
• Device Sequence Number: 1
• Product Code: ITW
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/10/2016

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: T2
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/07/2013
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 15 YR
• Patient Weight: 59