MAUDE Adverse Event Report: TACTILE SYSTEMS TECHNOLOGY INC.DBA TACTILE MEDICAL FLEXITOUCH PLUS SYSTEM; PNEUMATIC COMPRESSION DEVIC

Model Number	PD32-G3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report tactile medical has not received information from the patients health care team to determine if there were pre-existing conditions that were the cause of this event, therefore the device is being reported as a possible cause.Patient indicated on survey that reported this incident that they are "not currently using" product.
Event or Problem Description
The patient was shipped a pd32-g3 controller, serial number (b)(4), a full leg medium left garment 3l-fl-md-l lot 117609 and a full leg medium right garment 3l-fl-md-r lot 117499 on (b)(6) 2020.On december 10, 2020 tactile medical received a completed survey from the patient that stated after using the machine 2 times, the right ankle was fractured in 2 places while machine was in use, patient went to hospital and received rehab.On december 11, 2020 clinical services talked to the patient and they stated they had a demo of the device and it worked fine.They stated when they went to use the device at home it fractured their ankle in 2 places.The patient went to (b)(6) hospital in (b)(6), at the hospital the patient was given a hard cast.The patient was referred to an orthopedic surgeon who they saw twice.They said the podiatrist who prescribed the flexitouch has not been told about this incident, and they haven't seen him since it was prescribed.

• Brand Name: FLEXITOUCH PLUS SYSTEM
• Common Device Name: PNEUMATIC COMPRESSION DEVIC
• Manufacturer (Section D): TACTILE SYSTEMS TECHNOLOGY INC.DBA TACTILE MEDICAL; 151 5th avenue nw; new brighton MN 55112
• MDR Report Key: 11143802
• Report Number: 3004183730-2021-00001
• Device Sequence Number: 847387
• Product Code: JOW
• UDI-Device Identifier: 00816305023381
• UDI-Public: (01)00816305023381
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K170216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 12/10/2020

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: PD32-G3
• Device Catalogue Number: PD32-G3
• Device Lot Number: 117609, 117499
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 01/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 102