Brand Name | DICKSON PARAFFIN BATH |
Type of Device | PARAFFIN THERAPY |
Manufacturer (Section D) |
FABRICACION Y MANUFACTURAS DE MEXICO S.A. DE C.V. |
maquiladoras 1387-1 col.ciudad |
industrial |
tijuana, b.c. c.p. 22444 |
MX 22444 |
|
Manufacturer (Section G) |
FABRICACION Y MANUFACTURAS DE MEXICO |
maquiladoras 1387-1 |
col. ciudad industrial |
tijuana, b.c. 22444 |
MX
22444
|
|
Manufacturer Contact |
kristin
kahle
|
15125 proctor ave |
city of industry, CA 91746
|
6269686681
|
|
MDR Report Key | 7571465 |
MDR Text Key | 110169931 |
Report Number | 2222003-2018-00002 |
Device Sequence Number | 1 |
Product Code |
IMC
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Other
|
Remedial Action |
Other |
Type of Report
| Initial |
Report Date |
02/27/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
No Information
|
Device Model Number | PB-107 |
Device Catalogue Number | PB-107 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
03/28/2014
|
Initial Date FDA Received | 06/05/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/14/2013 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|