MAUDE Adverse Event Report: FABRICACION Y MANUFACTURAS DE MEXICO S.A. DE C.V. DICKSON PARAFFIN BATH; PARAFFIN THERAPY

Model Number PB-107

Device Problem Overheating of Device (1437)

Patient Problem Burning Sensation (2146)

Event Date 03/22/2014

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• 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

• Date FDA Received: 06/05/2018
• 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
• Date Manufacturer Received: 03/28/2014
• 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