MAUDE Adverse Event Report: TACTILE SYSTEMS TECHNOLOGY DBA TACTILE MEDICAL FLEXITOUCH SYSTEM; POWERED INFLATABLE TUBE MASSAGER

Model Number PD32-U

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

Patient Problem Swelling (2091)

Event Date 05/31/2016

Event Type  Injury  

Manufacturer Narrative

Patient plans to resume treatment with the device when cleared by her surgeon after her reconstructive surgery is complete.No additional issues have been reported.Follow up with the physician is in process.It is unknown whether the single device treatment contributed to the deflation and leakage of the tissue expander.

Event Description

The patient has a history of breast cancer resulting in a double mastectomy.Patient is undergoing breast reconstruction and has tissue expanders in place as part of her post mastectomy breast reconstruction.Patient was diagnosed with lymphedema in her right arm and trunk in the past 6 months and was prescribed the device as part of her lymphedema treatment.Patient received the device on (b)(6) 2016 and was trained on (b)(6) 2016.The training was uneventful.Patient had one treatment with the device post training and within 24 hours she noticed increased swelling and erythema in her non affected left breast area.She reported no pain or warmth in the breast tissue.Patient reported that her physician did not believe she had an infection but prescribed antibiotics as a precaution.Patient left for a business trip.Upon her return 2 weeks later, her swelling and erythema remained.She was seen by her surgeon who conducted a ct scan and it was determined that the tissue expander had partially deflated and fluid had leaked into the left breast area.There was no infection.Patient states that the surgeon indicated that her prior radiation may have weakened the surrounding breast tissue.The expander was left in place and patient was monitored for the duration of her phase one reconstruction with no other reported complications.She is scheduled to undergo reconstructive surgery as planned in early (b)(6).

• Brand Name: FLEXITOUCH SYSTEM
• Type of Device: POWERED INFLATABLE TUBE MASSAGER
• Manufacturer (Section D): TACTILE SYSTEMS TECHNOLOGY DBA TACTILE MEDICAL; minneapolis MN
• Manufacturer Contact: 1331 tyler street ne; suite 200; minneapolis, MN 55413 ; 8664353948
• MDR Report Key: 5763286
• MDR Text Key: 48622061
• Report Number: 3004183730-2016-00001
• Device Sequence Number: 1
• Product Code: IRP
• Combination Product (y/n): N
• PMA/PMN Number: K120972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial
• Report Date: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PD32-U
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/30/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 84