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

Model Number T2

Device Problem Fracture (1260)

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

Event Date 01/09/2014

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Subject was playing volleyball and landed off a block and the ankle brace snapped, causing complaintant to roll right ankle, resulting in tearing two ligaments and bruises.

• 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 66030-1151 ; 9138567511
• MDR Report Key: 5510472
• MDR Text Key: 40675765
• Report Number: 1910082-2016-00002
• 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
• 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

• 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
• Initial Date Manufacturer Received: 01/11/2014
• Initial Date FDA Received: 03/18/2016
• 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: 17 YR
• Patient Weight: 59