MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-05-22 for FLEXITOUCH SYSTEM PD32-U manufactured by Tactile Systems Technology Dba Tactile Medical.
[5919413]
Patient experienced dyspnea (shortness of breath) during device use. Patient was taken to the hospital by ambulance but died during transport. Patient had used the device previously on 3 or 4 separate days with one other incident of dyspnea, which resolved. This occurred on the day prior. After resolution, she was seen at the physical therapy clinic, was treated for anemia and received a blood transfusion.
Patient Sequence No: 1, Text Type: D, B5
[13416156]
Physician follow up occurred with the patient's primary care doctor who prescribed the device. The primary care doctor indicated that she was not part of the care team at the time of the emergent hospital transfer and no cause of death was established on hospital arrival. No autopsy was performed. There was a temporal relationship between device use and dyspnea, but this does not clarify the mechanism of her clinical deterioration. The relationship of the device use to dyspnea and death is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004183730-2015-00001 |
| MDR Report Key | 4802260 |
| Report Source | 05 |
| Date Received | 2015-05-22 |
| Date of Report | 2015-05-21 |
| Date of Event | 2015-04-08 |
| Date Mfgr Received | 2015-04-23 |
| Device Manufacturer Date | 2015-03-26 |
| Date Added to Maude | 2015-05-29 |
| 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. N.E. STE 200 |
| Manufacturer City | MINNEAPOLIS MN 55413 |
| Manufacturer Country | US |
| Manufacturer Postal | 55413 |
| Manufacturer G1 | TACTILE SYSTEMS TECHNOLOGY INC |
| Manufacturer Street | 4824 PARK GLEN RD. |
| Manufacturer City | MINNEAPOLIS MN 55416 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55416 |
| 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 | 2015-05-22 |
| Returned To Mfg | 2015-05-05 |
| Model Number | PD32-U |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Death | 2015-05-22 |