MAUDE Adverse Event Report: THE HYGENIC CORPORATION THERABAND; EXERCISER, NON-MEASURING

Model Number 081457118

Device Problem Naturally Worn (2988)

Patient Problems Hemorrhage/Bleeding (1888); Skin Tears (2516)

Event Date 05/22/2017

Event Type  malfunction  

Event Description

The patient was exercising in the outpatient physical therapy gym.She was holding onto a blue thera-tube and sidestepping when it snapped and hit her left hand.The patient was on blood thinners so she developed a small skin tear with bleeding.During activity the thera-tubing gave way due to repetitive usage.This is an item that is on a wall mounted device that is used multiple times.It appears to have worn out and will be replaced with new tubing.

• Brand Name: THERABAND
• Type of Device: EXERCISER, NON-MEASURING
• Manufacturer (Section D): THE HYGENIC CORPORATION; 1245 home avenue; akron OH 44310
• MDR Report Key: 6610491
• MDR Text Key: 76628098
• Report Number: 6610491
• Device Sequence Number: 1
• Product Code: ION
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/30/2017,05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 081457118
• Device Catalogue Number: 564765
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/30/2017
• Event Location: Hospital
• Date Report to Manufacturer: 05/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR