MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-09 for MODPOD 12.1000 manufactured by Hollywog, Llc.
[92862358]
The dhr review shows the device performed as intended when it was manufactured. The device was evaluated. Unable to replicate customer's complaint, operated to spec. Power pcb was re-aligned so the ports and switch were more easily accessible.
Patient Sequence No: 1, Text Type: N, H10
[92862359]
The device has full screen functionality, but will not pull at all. He and his ca has tried turning off and on the device. When asked to calibrate his device, it will not bring him to the screen to calibrate. Also, the patient switch would not end treatment previously, so the ca is sending back the patient switch.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008585473-2017-00032 |
| MDR Report Key | 7014825 |
| Date Received | 2017-11-09 |
| Date of Report | 2017-11-09 |
| Date of Event | 2017-10-05 |
| Date Mfgr Received | 2017-10-09 |
| Device Manufacturer Date | 2015-08-31 |
| Date Added to Maude | 2017-11-09 |
| 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 | MR. MICHAEL TREAS |
| Manufacturer Street | 2830 AMNICOLA HIGHWAY |
| Manufacturer City | CHATTANOOGA TN 374063605 |
| Manufacturer Country | US |
| Manufacturer Postal | 374063605 |
| Manufacturer Phone | 4233057778 |
| Manufacturer G1 | HOLLYWOG, LLC |
| Manufacturer Street | 2830 AMNICOLA HIGHWAY |
| Manufacturer City | CHATTANOOGA TN 37406 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37406 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MODPOD |
| Generic Name | THERAPEUTIC POWERED TRACTION DEVICE. |
| Product Code | ITH |
| Date Received | 2017-11-09 |
| Returned To Mfg | 2017-10-19 |
| Model Number | 12.1000 |
| Catalog Number | 12.1000 |
| Device Availability | R |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLLYWOG, LLC |
| Manufacturer Address | 2830 AMNICOLA HIGHWAY CHATTANOOGA TN 374063605 US 374063605 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2017-11-09 |