MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-30 for FLEXITOUCH SYSTEM PD32-U manufactured by Tactile Systems Technology Dba Tactile Medical.
[48622061]
Patient plans to resume treatment with the device when cleared by her surgeon after her reconstructive surgery is complete. No additional issues have been reported. Follow up with the physician is in process. It is unknown whether the single device treatment contributed to the deflation and leakage of the tissue expander.
Patient Sequence No: 1, Text Type: N, H10
[48622062]
The patient has a history of breast cancer resulting in a double mastectomy. Patient is undergoing breast reconstruction and has tissue expanders in place as part of her post mastectomy breast reconstruction. Patient was diagnosed with lymphedema in her right arm and trunk in the past 6 months and was prescribed the device as part of her lymphedema treatment. Patient received the device on (b)(6) 2016 and was trained on (b)(6) 2016. The training was uneventful. Patient had one treatment with the device post training and within 24 hours she noticed increased swelling and erythema in her non affected left breast area. She reported no pain or warmth in the breast tissue. Patient reported that her physician did not believe she had an infection but prescribed antibiotics as a precaution. Patient left for a business trip. Upon her return 2 weeks later, her swelling and erythema remained. She was seen by her surgeon who conducted a ct scan and it was determined that the tissue expander had partially deflated and fluid had leaked into the left breast area. There was no infection. Patient states that the surgeon indicated that her prior radiation may have weakened the surrounding breast tissue. The expander was left in place and patient was monitored for the duration of her phase one reconstruction with no other reported complications. She is scheduled to undergo reconstructive surgery as planned in early (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004183730-2016-00001 |
| MDR Report Key | 5763286 |
| Date Received | 2016-06-30 |
| Date of Report | 2016-06-30 |
| Date of Event | 2016-05-31 |
| Date Mfgr Received | 2016-05-30 |
| Date Added to Maude | 2016-06-30 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Street | 1331 TYLER STREET NE SUITE 200 |
| Manufacturer City | MINNEAPOLIS MN 55413 |
| Manufacturer Country | US |
| Manufacturer Postal | 55413 |
| Manufacturer Phone | 8664353948 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FLEXITOUCH SYSTEM |
| Generic Name | POWERED INFLATABLE TUBE MASSAGER |
| Product Code | IRP |
| Date Received | 2016-06-30 |
| Model Number | PD32-U |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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. Required No Informationntervention | 2016-06-30 |