MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-06-01 for FLEXITOUCH SYSTEM PD32-120 manufactured by Tactile Systems Technology Inc..
[1200026]
First received report from our call to the patient for her 60 day survey in 2009 - the first 3 days client used the flexitouch device without incident noting that the swelling in her legs was reduced. Device not used the next 2 days, legs started to swell. The next day device used in the a. M. Client reported "to get the swelling down, i laid on floor with my legs propped up, the swelling went down" (twice that day). That afternoon the device was used again. Near the end of the cycle (55 in. ) client needed to stop the device to urinate. Client begain having trouble breathing and paramedics were called client reported quit breathing just as they walked in the door (less than 10 minutes after getting off the device). Client was admitted to icu for 6 days. The doctors said client had experienced flash pulmonary edema that led fluid to build up causing the mitral valve to begin leaking.
Patient Sequence No: 1, Text Type: D, B5
[8145183]
The patient has a history of respiratory failure/pulmonary edema, asthma and copd, including two episodes of acute respiratory failure/pulmonary edema documented in her chart. The device is labeled as contraindicated for pulmonary edema. Despite this potential caution, the physician chose to proceed with device order as patient tolerated manual lymphatic drainage treatment previously. The patient did not use the device as prescribed. The prescribed protocol instructed patient to use device on one extremity in morning and other extremity in evening. Reported incident occurred after patient did not use device according to prescription. Patient did not use device for several days which allowed fluid accumulation in her legs. Thereupon, she used the device twice in one day with legs elevated without waiting the instructed period of time between treatments. In a follow up conversation with the therapist, the therapist determined that ongoing use of the device was no longer appropriate and facilitated a discharge order for the device from the doctor dated 2009. Device pick up from patient is in progress. Follow up with physician was attempted with many calls over two weeks. The physician has not returned the calls. The manufacturer has not been able to obtain a statement from the physician regarding whether she believes device usage contributed to this episode. The manufacturer will submit a supplemental report if additional necessary information is received from physician.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004183730-2009-00001 |
| MDR Report Key | 1397197 |
| Report Source | 04 |
| Date Received | 2009-06-01 |
| Date of Report | 2009-06-01 |
| Date of Event | 2009-03-15 |
| Date Mfgr Received | 2009-05-07 |
| Device Manufacturer Date | 2009-02-01 |
| Date Added to Maude | 2009-06-08 |
| 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. 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 | 2009-06-01 |
| Model Number | PD32-120 |
| 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. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2009-06-01 |