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

Model Number	PD32-G3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	10/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was prescribed a pd32-g3 pneumatic compression device for treatment of lower extremity lymphedema and received the device on (b)(6) 2021.On (b)(6) 2024, the patient contacted tactile medical and spoke with clinical patient services reporting the hose on the left leg garment caused a large wound.He stated that he had not used the device between 2021, after initially receiving the device, and on (b)(6) 2024.No reason was given for the pause in usage.Though during this time, he had various vascular procedures and a right leg amputation.With clearance and oversight of his treating clinician, the patient resumed use of device on (b)(6) 2024, three times per week with assistance of a home health aide.He had several comorbidities including wounds, heel trauma, and dvt of left lower extremity being medically managed.A home health aide assisted with device usage and application of garment, which patient noted they felt was being wrapped tightly, over two-layer bandaging, foam padding and koban from toes to knee on left leg.Due to paraplegia, the left leg externally rotated toward the hoses within the garment.The patient reported he has no sensation in his left leg, thus was unable to feel any pain or discomfort.Over the course of approximately six weeks of device use, the patient's wound care nurse noted skin changes from redness, to weeping, followed by skin breakdown, and worsening of condition which led them to contact the patient's health care team on (b)(6) 2024.The patient was advised to stop device use for the time being.The patient's health care team subsequently performed debridement of the wound to improve recovery.Tactile medical's chief medical officer reviewed the reported event on 11/15/2024, concluding the tubing location on the garment and the patient's limb weightbearing onto the tubing without leg sensation was likely a contributory factor to wound/skin breakdown of lateral lower left leg.The patient has since been given clearance from his clinician to resume treatment with device and daily compression for management of lymphedema and wounds.

• Brand Name: FLEXITOUCH PLUS SYSTEM
• Common Device Name: PNEUMATIC COMPRESSION DEVICE
• Manufacturer (Section D): TACTILE SYSTEMS TECHNOLOGY INC DBA TACTILE MEDICAL; 151 5th avenue nw; new brighton MN 55112
• Manufacturer (Section G): TACTILE SYSTEMS INC. DBA TACTILE MEDICAL; 151 5th ave nw; new brighton MN 55112
• Manufacturer Contact: sunday hoy ; 151 5th ave nw; new brighton, MN 55112 ; 6123555121
• MDR Report Key: 20751762
• Report Number: 3004183730-2024-00003
• Device Sequence Number: 8587587
• Product Code: JOW
• UDI-Device Identifier: 00816305021400
• UDI-Public: 0100816305021400
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K203178
• 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
• Type of Report: Initial
• Report Date (Section B): 11/21/2024

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: PD32-G3
• Device Catalogue Number: PD32-G3
• Device Lot Number: 638439,118132,118133
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2021
• 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: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 95 KG