MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-09-19 for FLEXITOUCH SYSTEM PD32-U manufactured by Tactile Systems Technology Inc.
[16128860]
Pt called indicating that he had been seen by a vascular surgeon for problems related a loss of blood flow to his right foot. The physician assessed that the tube that had been placed in the pt's right leg during a femoral-popliteal arterial bypass in (b)(6) 2010 was blocked or crushed. The pt was prescribed the flexitouch in (b)(6) 2011 to address lymphedema secondary to cvi. On (b)(6) 2011, he was trained on the flexitouch device. His training was uneventful. He had 3 treatments between (b)(6) 2011. He has not used the device since that time, even though his treatment prescription indicated daily one hour treatments. Based on his current complications related to the blockage of the arterial tube, the physician instructed the pt to stop using the flexitouch device. The physician has not been able to determine the cause of the damage to the arterial tube. Since receiving the device, the pt has had multiple surgeries wherein a compression cuff and tourniquet were utilized. The pt indicated that the physician thought that the compression cuff and/or tourniquet may have contributed to the crushing of the arterial tube. The pt was being scheduled for surgery related to the complications associated with his poor vascular condition and was being assessed for further, more proximal amputation. When contacted directly by the company, the physician could not assess one way or the other whether the flexitouch device had any impact on the damaged arterial tubes.
Patient Sequence No: 1, Text Type: D, B5
[16336837]
The mfr does not believe the complications experienced by the pt subsequent to use of the flexitouch device are the result of the flexitouch. The pt has an extensive medical history of related issues included a previous amputation. In addition, the pt did not report any discomfort or pain associated with the 3 treatments he had with the device. The tubes associated with femoral popliteal arterial bypass are not likely to be damaged by the mild pressures exerted by the flexitouch device. In addition, the pt had recent compression with compression cuffs and tourniquets during his recent surgeries. The treating clinician has not been able to ascertain that the device caused or contributed to the clinical complications of the pt.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004183730-2011-00001 |
| MDR Report Key | 2261859 |
| Report Source | 04 |
| Date Received | 2011-09-19 |
| Date of Report | 2011-08-22 |
| Date of Event | 2011-06-12 |
| Date Mfgr Received | 2011-08-22 |
| Device Manufacturer Date | 2011-03-01 |
| Date Added to Maude | 2011-09-26 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1331 TYLER ST NE, STE 200 |
| Manufacturer City | MINNEAPOLIS MN 55413 |
| Manufacturer Country | US |
| Manufacturer Postal | 55413 |
| Manufacturer Phone | 6123555100 |
| 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 | 2011-09-19 |
| Model Number | PD32-U |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TACTILE SYSTEMS TECHNOLOGY INC |
| Manufacturer Address | MINNEAPOLIS MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-09-19 |