MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-05 for DICKSON PARAFFIN BATH PB-107 manufactured by Fabricacion Y Manufacturas De Mexico S.a. De C.v..
[110169931]
Evaluation of the unit found that the chassis had been entered by an unknown third party. Wiring connectors and thermostat connections were found to be modified and not meeting device specifications. The failure was documented for trend analysis. Credit was issued to customer after return.
Patient Sequence No: 1, Text Type: N, H10
[110169932]
Customer reported an issue where a unit got hot and burned a user. Multiple attempts to contact the distributer failed and therefore additional event details could not be obtained. The customer that contacted us did not clarify the severity of the burn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2222003-2018-00002 |
| MDR Report Key | 7571465 |
| Date Received | 2018-06-05 |
| Date of Report | 2018-02-27 |
| Date of Event | 2014-03-22 |
| Date Mfgr Received | 2014-03-28 |
| Device Manufacturer Date | 2013-10-14 |
| Date Added to Maude | 2018-06-05 |
| 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 | KRISTIN KAHLE |
| Manufacturer Street | 15125 PROCTOR AVE |
| Manufacturer City | CITY OF INDUSTRY CA 91746 |
| Manufacturer Country | US |
| Manufacturer Postal | 91746 |
| Manufacturer Phone | 6269686681 |
| Manufacturer G1 | FABRICACION Y MANUFACTURAS DE MEXICO |
| Manufacturer Street | MAQUILADORAS 1387-1 COL. CIUDAD INDUSTRIAL |
| Manufacturer City | TIJUANA, B.C. 22444 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22444 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DICKSON PARAFFIN BATH |
| Generic Name | PARAFFIN THERAPY |
| Product Code | IMC |
| Date Received | 2018-06-05 |
| Model Number | PB-107 |
| Catalog Number | PB-107 |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FABRICACION Y MANUFACTURAS DE MEXICO S.A. DE C.V. |
| Manufacturer Address | MAQUILADORAS 1387-1 COL.CIUDAD INDUSTRIAL TIJUANA, B.C. C.P. 22444 MX 22444 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-05 |