MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2016-07-14 for FLEXITOUCH SYSTEM PD32-U manufactured by Tactile Systems Technology Dba Tactile Medical.
[49518303]
The pneumatic device was prescribed to address severe forearm swelling; the etiology of the swelling is not clear. The records clarify that the treating physicians were also never sure on the cause of the edema. In general, this forearm swelling might occur simply due to the increased forearm blood flow (the shunt); due to blood leakage at the av fistula anastomotic sites; due to venous hypertension from the high flow state; or perhaps due to unknown prior forearm lymphatic dysfunction, unmasked by the high flow state. This latter outcome (lymphedema in the context of a high flow avf) is a known complication of avfs in any forearm. Of course, any other cause of edema might have also existed (e. G. , a capillary leak syndrome), but there is no possibility now of determining the cause of edema. The occurrence of a hematoma after device use could have been due to spontaneous avf bleeding or may have been due to device compression near the fistula. Once the hematoma was created, ulcer formation and avf failure apparently followed. Given the complex medical history, this was a high risk limb and there are several mechanisms present that may have contributed. However, use of compression (including pneumatic device use as occurred here) may have contributed to this event.
Patient Sequence No: 1, Text Type: N, H10
[49518304]
Patient has a history of end stage renal disease and was receiving dialysis accessed by a brachiocephalic arterio-venous fistula. Her doctor prescribed pneumatic compression device to treat uncontrolled and severe swelling in her forearm and hand. She received the pneumatic compression device and was trained on its use on march 28, 2016. She used the device once per day for the first week and then increased usage to twice per day the next week as prescribed by her physician. The patient reported a hematoma developed along her arm from her hand to her elbow on the treated arm. She was hospitalized for six days experiencing severe pain in her arm and a resulting wound in the same location.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004183730-2016-00002 |
| MDR Report Key | 5793853 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2016-07-14 |
| Date of Report | 2016-07-14 |
| Date of Event | 2016-04-11 |
| Date Mfgr Received | 2016-06-30 |
| Date Added to Maude | 2016-07-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 1331 TYLER STREEE NE SUITE 200 |
| Manufacturer City | MINNEAPOLIS MN 55413 |
| Manufacturer Country | US |
| Manufacturer Postal | 55413 |
| Manufacturer Phone | 8664353948 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXITOUCH SYSTEM |
| Generic Name | POWERED INFLATABLE TUBE MASSAGER |
| Product Code | IRP |
| Date Received | 2016-07-14 |
| Model Number | PD32-U |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TACTILE SYSTEMS TECHNOLOGY DBA TACTILE MEDICAL |
| Manufacturer Address | MINNEAPOLIS MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-07-14 |