MAUDE Adverse Event Report: BTE TECHNOLOGIES ER; EVALUATION DEVICE

Model Number ER MODEL ER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Muscle/Tendon Damage (4532)

Event Date 06/09/2021

Event Type  Injury  

Manufacturer Narrative

The equipment did not cause nor contribute to the incident that occurred during post offer employment testing (poet).Poet protocol simulates job tasks that candidates would be required to perform to determine their capability to perform the job.Job candidates give their maximum effort to qualify for the job, and may extend themselves beyond their physical capability.Candidates are in full control of the exercise.The device is passive during the testing; there are no motors or actuators.The injury occurred during exercise that was not bte-device specific and could have been performed against a wall.During a push test, the candidate was in proper position (in a staggered stance).While pushing, he injured his achilles tendon in the forward foot during the exercise.The device did not malfunction, and there is no evidence it was used incorrectly.There is no need to conduct the specific device evaluation.Root causes: the candidate injured himself while pushing against the device.The injury was caused by the extension of body parts during an exercise intended to duplicate the requirements of the job the candidate applied for.The root cause was the exercise itself and the physical capability of the candidate who was performing the pushing exercise.The bte product, although involved in the incident, was not the direct or indirect cause of the injury, as the injury would have occurred even if the candidate performed the "pushing" activity against a wall, instead of the bte product.Note related to (b)(4).The handles are mounted on the equipment for push exercises.The equipment did not malfunction.

Event Description

Job candidate injured achilles tendon during post offer employment testing (poet).He walked out of the clinic on his own but limping and in pain.He decided to seek medical attention.The medical place put his foot in a boot type brace and told him to visit an orthopedist for further examination.Results of the orthopedic visit are unknown.

• Brand Name: ER
• Type of Device: EVALUATION DEVICE
• Manufacturer (Section D): BTE TECHNOLOGIES; 7455-l new ridge rd.; havover MD 21076
• Manufacturer (Section G): BTE TECHNOLOGIES; 7455-l new ridge rd.; hanover MD 21076
• Manufacturer Contact: ewa kaczanowska ; 7455-l new ridge rd; hanover, MD 21076 ; 4108500333
• MDR Report Key: 12139139
• MDR Text Key: 260673840
• Report Number: 1119903-2021-00001
• Device Sequence Number: 1
• Product Code: IKK
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: ER MODEL ER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/06/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR