MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-02-15 for FLEXITOUCH SYSTEM PD32-U manufactured by Tactile Systems Technology Inc..
[2524867]
Pt began using device after initial training on (b)(6), 2012. She used the device daily but had difficulty donning so contacted the product specialist for add'l training/assistance. Product specialist conducted a home visit on (b)(6) to assess and provide add'l training on donning the device. Product specialist provided instruction, observed the pt don the device on her left arm and trunk and observed the treatment. The treatment was well tolerated by the pt with no complaints of breathing difficulties. The product specialist indicated that there was nothing unusual about the treatment. The pt also indicated that she was having discomfort in her legs and difficulty getting comfortable. These comments did not appear related to her arm lymphedema or treatment. She said her knees ached and she had an mri the previous week which showed some fluid around the knee. Product specialist indicated that although the pt has a history of lymphedema in the lower extremity, she was only ordered upper extremity treatment at this time. That evening the pt was admitted to the hospital with shortness of breath, fluid around her heart/lungs diagnosed as possible pneumonia and congestive heart failure. She was placed on a ventilator. She was discharged on (b)(6), 2012.
Patient Sequence No: 1, Text Type: D, B5
[9650699]
The mfr has been unable to ascertain whether the complications experienced by the pt are related to pneumatic device usage. F/u inquiries to her treating clinicians have not been returned. However, the pt had used the device in the clinic repeatedly for several weeks w/o complications prior to obtaining her unit for home use. The pt also tolerated in clinic manual lymphatic massage therapy which is similar to the treatment effect of the pneumatic device w/o complications. Documentation provided to the mfr in support of the device order did not note any contraindications or medical history that would suggest the pt would not tolerate the device treatment. However, the mfr has been unable to confirm with the treating cardiac and pulmonary doctors whether they believe there is any connection to the pts' use of the pneumatic device and her hospitalization.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004183730-2012-00001 |
| MDR Report Key | 2465998 |
| Report Source | 04 |
| Date Received | 2012-02-15 |
| Date of Report | 2012-02-15 |
| Date of Event | 2012-01-19 |
| Date Mfgr Received | 2012-01-19 |
| Device Manufacturer Date | 2011-12-01 |
| Date Added to Maude | 2012-02-24 |
| 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 | 2012-02-15 |
| 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. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2012-02-15 |