MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-10-06 for FLEXITOUCH SYSTEM PD32-U manufactured by Tactile Systems Technology Inc.
[19104317]
Patient's wife reports that the patient experienced pain on right leg while receiving device treatment of left leg during training. Wife reported that patient did not feel well for the next 2 days with symptoms of shortness of breath, fever, and pain. Patient was taken to the emergency room 2 days after his device training. Wife reports emergency room doctor indicated patient may have had mild heart attack and is now diagnosed with congestive heart failure and chronic renal failure.
Patient Sequence No: 1, Text Type: D, B5
[19116618]
The manufacturer does not believe the single device treatment received by the patient had any reasonable relationship to the patient's recent hospitalization and possible diagnosis of mild heart attack, chronic renal failure or congestive heart failure. Manufacturer has followed up with the clinical care team who indicate that the patient's current condition is the progression of his chronic illnesses and is not related to his use of the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004183730-2011-00002 |
| MDR Report Key | 2297952 |
| Report Source | 04 |
| Date Received | 2011-10-06 |
| Date of Report | 2011-10-06 |
| Date of Event | 2011-09-09 |
| Date Mfgr Received | 2011-09-12 |
| Device Manufacturer Date | 2011-08-01 |
| Date Added to Maude | 2011-10-18 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 1331 TYLER ST. N.E. SUITE 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 | 2011-10-06 |
| Model Number | PD32-U |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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. Hospitalization; 2. Required No Informationntervention | 2011-10-06 |