MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-03 for VASCUTHERM4 THERAPY DEVICE VT4 0P9PTVT400 manufactured by Thermotek, Inc..
[144100588]
Device not returned for evaluation and no information was given other than dme wanted to know if compliance was retrievable for device and that they wanted to know in response to an adverse event, but no details of event were given and no information about device, other than model, was supplied to the mfg.
Patient Sequence No: 1, Text Type: N, H10
[144100589]
Distributor called and wanted to know if there was a way to track compliance on the vt4; sales advised the caller they would need to check what was retrievable; they also asked if this was a general question or related to an adverse event. Distributor responded it ws to an adverse event. Sales forwarded email to quality; quality emailed distributor and advised to fill our an alleged patient injury form and contact customer service for an rma so that the device could be returned and evaluated. Distributor responded that they only wanted an answer to their question and did not want to return the device. Advised customer it was in every ones best interest to have the device evaluated. Distributor did not respond to multiple requests for feedback or acceptance of evaluation of device free of charge. The last contact made by (b)(4) to the distributor was (b)(6) 2019 and they responded that they haven't heard anything more from the doctor about the patient or incident. Will follow up with a supplemental report if additional information is received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1648700-2019-00001 |
| MDR Report Key | 8578147 |
| Date Received | 2019-05-03 |
| Date of Report | 2019-04-25 |
| Date Added to Maude | 2019-05-03 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SARA LEE |
| Manufacturer Street | 1200 LAKESIDE PARKWAY #200 |
| Manufacturer City | FLOWER MOUND TX 75028 |
| Manufacturer Country | US |
| Manufacturer Postal | 75028 |
| Manufacturer G1 | THERMOTEK, INC. |
| Manufacturer Street | 1200 LAKESIDE PARKWAY #200 |
| Manufacturer City | FLOWER MOUND TX 75028 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75028 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VASCUTHERM4 THERAPY DEVICE |
| Generic Name | VT4 |
| Product Code | ILO |
| Date Received | 2019-05-03 |
| Model Number | VT4 |
| Catalog Number | 0P9PTVT400 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THERMOTEK, INC. |
| Manufacturer Address | 1200 LAKESIDE PARKWAY #200 FLOWER MOUND TX 75028 US 75028 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-03 |