MAUDE Adverse Event Report: NORTECH LABORATORIES, INC. INSTAHEET INSTANT HOT COMPRESS ; DISPOSABLE HOT PACK

Model Number TKINST68H

Device Problem Temperature Problem (3022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2015

Event Type  malfunction  

Manufacturer Narrative

A review of the mfg records associated with instaheet device, part number tkinst68h, lot# 021510, revealed no non-conformances were found.Additional info regarding the reported complaint, including info regarding the temperature testing conducted, was requested multiple times from the distributor.Additionally, recently the company contacted the user facility directly to try to obtain specific info regarding the reported event.The facility initially responded that the issues have been closed, and also recommended that the company follow up with the distributor, or a specific individual at the hospital.Further follow up to the hospital occurred, however to date, no response has been received.Regarding the claim that product exhibited temperatures in excess of the maximum 160 degrees, nortech conducted temperature testing on 20 additional samples from the complaint lot # 021510, as well as 20 samples from the lot manufactured immediately prior to the complaint lot # 011529, and 20 samples from the lot manufactured immediately following the complaint lot # 021523.The test results confirm that all temperatures were well within specification, and were significantly lower than the device's maximum temperature of 160 degrees f.The maximum temperature recorded from each lot was as follows: lot#: 021510 (complaint lot): 142.3 f.Lot #: 021523: 143.5 f.Lot #: 011529: 142.6 f.This is the only reported complaint nortech has received regarding temperatures above 160 degrees f since the device was introduced in january 2006.Nortech is unable to duplicate the reported complaint.The cause of the reported complaint regarding temperatures in excess of 160 degrees f is inconclusive since the records and testing does not provide any evidence to support the claim of a defective product.Also, the cause of the packs which were cold when activated, and activated upon receipt is inconclusive.The complaint rates for packs which were cold when activated for the past 24 months is (b)(4), while the complaint rates for devices which were activated upon receipt is (b)(4).This complaint will be tracked and trended.If additional info is provided regarding, a supplemental report will be submitted.

Event Description

The distributor reported a complaint involving a hospital's report concerning issues with their disposable instaheet hot packs; i.E., packs exceeding maximum temperature of 160 degrees f (stated above 180 degrees f).Additionally, there were hot packs which were reported to be "cold" when activated, and packs which were activated upon receipt.There was no pt involved in the reported complaint.((b)(4)).

• Brand Name: INSTAHEET INSTANT HOT COMPRESS
• Type of Device: DISPOSABLE HOT PACK
• Manufacturer (Section D): NORTECH LABORATORIES, INC.; 125 sherwood ave.; farmingdale NY 11735
• Manufacturer Contact: joshua nazarieh ; 125 sherwood ave.; farmingdale, NY 11735 ; 6315011452
• MDR Report Key: 4922636
• MDR Text Key: 22403101
• Report Number: 2415591-2015-00001
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Not Applicable
• Report Date: 03/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2016
• Device Model Number: TKINST68H
• Device Lot Number: 021510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1