FDA Adverse Event Injury Summary report: N

HENRY SCHEIN

MDR report key: 7253266 · Received February 8, 2018

Report

Report Number: 2411236-2018-00002
Event Type: Injury
Date Received: February 8, 2018
Date of Event: November 11, 2017
Report Date: February 21, 2018
Manufacturer: JIANGSU INTCO MEDICAL PRODUCTS CO., LTD.
Product Code: IMD
Adverse Event: Yes
Report Source: Distributor report
Reporter Location: VA, US
Reporter Occupation: PATIENT

Narratives

Description of Event or Problem · 0

THE INITIAL REPORT SUBMITTED ON 02/08/2018 FOR THIS INCIDENT THE PATIENT PROVIDED US WITH THE INCORRECT CATALOG NUMBER. WE WERE INFORMED ON 2/21/2018 BY OUR INSURANCE CARRIER THE PATIENT REPORTED THE ACTUAL CATALOG NUMBER INVOLVED AND USED BY THE PATIENT AS CATALOG NUMBER 112-6145. THIS ITEM IS MANUFACTURED BY A DIFFERENT MANUFACTURER; THEREFORE, WE HAVE SENT THE REPORT TO THE MANUFACTURER OF THIS PRODUCT AND HAVE UPDATED THE INFORMATION ON: SUSPECT MEDICAL DEVICE AND THE MANUFACTURER INFORMATION: USER FACILITY/IMPORTER ON THIS MEDWATCH REPORT.

Description of Event or Problem · 1

PER A LETTER FROM A FEMALE PATIENT, SHE REPORTS EXPERIENCING LOWER BACK PAIN AND PLACED A COLD PACK WRAPPED IN A TOWEL ON HER LOWER BACK. SHORTLY AFTER WHEN THE COLD PACK WAS REMOVED, SHE NOTICED A BURN ON HER BACK WHICH REQUIRED MEDICAL ATTENTION. SHE IS STILL RECEIVING MEDICAL ATTENTION FOR THIS WOUND; HOWEVER NO SPECIFICS WAS PROVIDED REGARDING THE MEDICAL TREATMENT RECEIVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
101428	HENRY SCHEIN	COMPRESS COLD INSTANT DISPOSABLE	IMD	JIANGSU INTCO MEDICAL PRODUCTS CO., LTD.		015HSN7006

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other