MAUDE Adverse Event Report: TACTILE SYSTEMS TECHNOLOGY INC DBA TACTILE MEDICAL AFFLOVEST; PERCUSSOR, POWERED-ELECTRIC

Model Number	8100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Multiple Fractures (4519)
Date of Event	01/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Returned product evaluation summary: returned small vest serial # (b)(6), battery, power supply and duffle bag.Battery has 5 bars on the fuel gauge, measured 16.71 volts on the multimeter.Tested battery on uba5 battery analyzer.Battery passed.Power supply measured 18.00 volts on the multimeter.Vest has 129 hours and 37 minutes run time.Vest passed motor sequence test.Ran therapy that was saved upon receipt of vest.All treatments functional and worked as they should with no issues.
Event or Problem Description
On january 4, 2024, the patient was taken to the emergency department by his parents because he had been sick.Upon examination, including x-rays, it was discovered the patient had multiple rib fractures though no cause was identified.During a follow appointment with his primary care physician (pcp) on january 23, 2024, the pcp assessment noted the patient's significant history of cerebral palsy and limited mobility indicating that could lead to brittle bones and that regular use of a percussive device may have contributed to the fractured ribs.Investigation of the rib fractures with dexa scan and discontinuation of use of the percussive device were also discussed at this appointment.Use of the device was discontinued and product was returned to the distributor that provided the product to the patient.On april 16, 2024, during the process of returning the product the parent informed the distributor of the event.The distributor notified manufacturer, tactile medical, on april 26, 2024.Use of the device was discontinued and product was returned.Tactile medical has received no indication of any further medical evaluations relating to the reported event.

• Brand Name: AFFLOVEST
• Common Device Name: PERCUSSOR, POWERED-ELECTRIC
• Manufacturer (Section D): TACTILE SYSTEMS TECHNOLOGY INC DBA TACTILE MEDICAL; 151 5th ave nw; new brighton MN 55112
• Manufacturer (Section G): TACTILE SYSTEMS TECHNOLOGY INC.DBA TACTILE MEDICAL; 151 5th ave nw; new brighton MN 55112
• Manufacturer Contact: sunday hoy ; 151 5th avenue nw; new brighton, MN 55112 ; 6123555121
• MDR Report Key: 19398331
• Report Number: 3004183730-2024-00002
• Device Sequence Number: 7753936
• Product Code: BYI
• UDI-Device Identifier: 00816305024005
• UDI-Public: 0100816305024005
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K122480
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: 8100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 05/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 74 KG