BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTAHEET INSTANT HOT COMPRESS

    MDR report key: 4943558 · Received July 23, 2015

    Report

    Report Number
    2415591-2015-00002
    Event Type
    Injury
    Date Received
    July 23, 2015
    Date of Event
    February 26, 2015
    Report Date
    March 4, 2015
    Manufacturer
    NORTECH LABORATORIES INC
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS ASSOCIATED WITH INSTAHEET DEVICE, PART NUMBER TKINST68H, LOT # 021510 WAS CONDUCTED AND REVEALED NO NON-CONFORMANCES. ADDITIONAL INFORMATION REGARDING THE REPORTED COMPLAINT WAS REQUESTED MULTIPLE TIMES FROM THE DISTRIBUTOR. ALSO, RECENTLY THE COMPANY CONTACTED THE USER FACILITY DIRECTLY TO TRY AND OBTAIN SPECIFIC INFORMATION REGARDING THE REPORTED EVENT. THE FACILITY RESPONDED TO THE COMPANY'S INITIAL QUESTIONS. HOWEVER, THE COMPANY SENT A FOLLOW UP REQUEST FOR SPECIFIC INFORMATION REGARDING THE EXACT TIME THAT THE HOT PACK WAS DISCONTINUED, AND WHETHER THE PATIENT'S "MONITORING/CHECKS" INCLUDED CHECKS OF THE HOT PACK SITE, OR CONSISTED OF STANDARD POST-OPERATIVE VITAL SIGNS MONITORING. THIS REQUEST HAS BEEN FORWARDED TO THE SITE'S LEGAL DEPARTMENT FOR GUIDANCE REGARDING SHARING INFORMATION WHICH THE SITE CONSIDERS TO BE CONFIDENTIAL AND PRIVILEGED. PLEASE NOTE THE FACILITY HAS CLARIFIED THEIR STATEMENT IN (B)(4) ABOUT THE HOT PACK BEING TOO HOT TO HOLD IN THEIR UNPROTECTED HAND. IT IS BELIEVED THAT THIS WAS NOTED BY CLINICAL STAFF WHO WERE NOT USING A SOFT CLOTH OR "BLUE EASY SLEEVE, " AS DIRECTED IN THE INSTAHEET INSTRUCTIONS FOR USE. IT IS UNKNOWN WHY AN INSTAHEET HOT PACK WAS APPLIED TO A MEDICATED POST-OPERATIVE PATIENT SINCE THE DEVICE IS INDICATED FOR USE "WHEN WARM THERAPY IS INDICATED." IT IS STANDARD MEDICAL PRACTICE THAT HEAT/WARM THERAPY IS NOT INDICATED POSTOPERATIVELY SINCE HEAT WILL INCREASE CIRCULATION AND INCREASE BLEEDING AND SWELLING TO THE AREA. IN ADDITION TO OFF LABEL USE OF THE DEVICE, THE INSTAHEET PACK INSTRUCTIONS FOR USE WERE NOT FOLLOWED. MORE SPECIFICALLY, THE DEVICE WAS PLACED ON THE PATIENT'S HOSPITAL GOWN AS A BARRIER AGAINST THE PATIENT'S SKIN. PER THE INSTAHEET HOT PACK INSTRUCTIONS FOR USE, THE DEVICE SHOULD BE USED WITH A SOFT CLOTH, OR NORTECH'S BLUE EASY SLEEVE, AND THE PATIENT SHOULD BE FREQUENTLY MONITORED TO GUARD AGAINST BUMS. THUS WHILE THE PATIENT'S CHART DOCUMENTS FREQUENT FOLLOW UPS WITH THE PATIENT, THE COMPANY IS AWAITING INFORMATION FROM THE SITE REGARDING WHETHER THIS MONITORING INCLUDED THE REQUIRED FREQUENT CHECKS OF THE HOT PACK SITE, AS STATED IN THE INSTRUCTIONS FOR USE. IT CANNOT BE ESTABLISHED FROM ANY OF THE INFORMATION PROVIDED WHETHER THE TEMPERATURE OF THE PACK EXCEEDED THE DEVICE'S MAXIMUM TEMPERATURE OF 160 DEGREES F. THE COMPANY CONDUCTED TEMPERATURE TESTING ON 20 SAMPLES FROM THE COMPLAINT LOT ((B)(4)), AND THE RESULTS WERE WELL WITHIN THE TEMPERATURE SPECIFICATION. THE AVERAGE ACTIVATION TEMPERATURE OF ALL SAMPLES WAS 134.19 F, AND THE MAXIMUM INDIVIDUAL TEMPERATURE RECORDED DURING THIS TESTING WAS 142.3 F. ALL TEMPERATURE MEASUREMENTS WERE SIGNIFICANTLY LOWER THAN THE DEVICE'S MAXIMUM TEMPERATURE OF 160 DEGREES F. ALSO, FOUR ADDITIONAL TEMPERATURE MEASUREMENTS AT 5, 10, 15 AND 20 MINUTE INTERVALS WERE RECORDED FOR EACH SAMPLE TESTED FROM THE COMPLAINT LOT. ALL DATA WAS AGAIN WELL WITHIN SPECIFICATION, AND THE DATA DEMONSTRATES THAT THE TEMPERATURE OF THE DEVICE IMMEDIATELY STARTS TO DEGRADE FOLLOWING ACTIVATION. MORE SPECIFICALLY, THE TESTING REVEALED THAT 20 MINUTES AFTER ACTIVATION, THE MAXIMUM INDIVIDUAL TEMPERATURE WAS 123.5F, AND THE AVERAGE TEMPERATURE OF ALL SAMPLES WAS 119.06 F. THIS IS THE ONLY REPORTED COMPLAINT NORTECH HAS RECEIVED REGARDING A PATIENT BUM SINCE THE DEVICE WAS INTRODUCED IN (B)(6) 2006. BASED UPON THE INFORMATION AVAILABLE TO DATE, THE CAUSE OF THE COMPLAINT IS ATTRIBUTED TO OFF-LABEL USE AND USER ERROR. THIS COMPLAINT WILL BE TRACKED AND TRENDED. IF ADDITIONAL INFORMATION IS PROVIDED BY THE FACILITY, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED A COMPLAINT INVOLVING THE INSTAHEET HOT PACK AND A PATIENT EXPERIENCING A SECOND DEGREE BURN, INCLUDING A 8 CM BLISTER. THE PATIENT IS REPORTED TO HAVE UNDERGONE A HYSTEROSCOPY ENDOMETRIAL ABLATION UNDER GENERAL ANESTHESIA IN THE HOSPITAL'S SAME DAY SURGERY DEPARTMENT. REGARDING APPLICATION OF THE INSTAHEET HOT PACK, THE FACILITY REPORTED THAT AT 8:38-8:39 AM, THE INSTAHEET PACK WAS PLACED ON THE PATIENT'S ABDOMEN, USING THE HOSPITAL GOWN AS BARRIER BETWEEN THE PATIENT SKIN AND THE DEVICE. THE PATIENT UNDERWENT SOME TYPE OF "MONITORING/CHECKS/OR SOME TYPE OF INTERVENTION" EVERY 1-23 MINUTES. AT 13:50 PM: THE PATIENT WAS DISCHARGED/TRANSFERRED FROM THE PACU TO SAME DAY SURGERY (SDS). AT SOME POINT, THE INSTAHEET HOT PACK WAS DISCONTINUED. AT 14:50 PM, THE PATIENT WAS DISCHARGED FROM SDS TO HOME WITH PAIN MEDICATION FOR HOME USE. LATER THAT SAME DAY, THE PATIENT IS REPORTED TO HAVE RETURNED TO THE EMERGENCY DEPARTMENT, WHERE THE PATIENT WAS ASSESSED BY AN EMERGENCY DEPARTMENT (ED) PROVIDER WHO THEN CONSULTED WITH A GYN SURGEON. THE SURGEON SAW AND ASSESSED THE PATIENT IN THE ED. ACCORDING TO THE PATIENT'S RECORD, NO INTERVENTIONS WERE PERFORMED OR ADMINISTERED IN THE ED. THE PATIENT WAS THEN DISCHARGED TO HOME WITH BACTROBAN TO APPLY TO THE BURN SITE AS INSTRUCTED. THE PATIENT'S LAST VISIT WITH THE GENERAL SURGERY CLINIC WAS ON (B)(6) 2015. THE PATIENT REPORTED NO PAIN FROM BURN SITE. THE WOUND WAS "ALMOST COMPLETELY EPITHELIALIZED. SEVERAL SMALL SCATTERED AREAS OF GRANULATION TISSUE REMAIN." THE PATIENT WAS RELEASED WITHOUT LIMITATIONS, AND DIRECTED TO FOLLOW-UP AS NEEDED IN THE SURGERY CLINIC. (B)(4): "ALTHOUGH THE PRODUCT'S EXTERNAL TEMPERATURE WAS NOT MEASURED CLINICAL STAFF REPORTED HOT PACKS OF THE SAME MODEL BECAME TOO HOT TO HOLD IN THEIR UNPROTECTED HAND. ALTHOUGH THE BURN WAS NOT DISCOVERED UNTIL THE PATIENT WAS DISCHARGED, IT IS ASSUMED THAT IS THE HEAT PACK WAS REMOVED EARLIER, THE EXTENT OF THE BURN COULD HAVE BEEN DECREASED." THE PATIENT RECEIVED THE FOLLOWING MEDICATIONS: FENTANYL 50 MCG IVP X 2; HYDROMORPHONE 0.4 MG IV X 3; ONDANSETRON 4 MG IVP X 1; IBUPROFEN 800 MG IV X1; ACETAMINOPHEN 1000 MG IV X 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480370 INSTAHEET INSTANT HOT COMPRESS DISPOSABLE INSTANT HOT PACK IMD NORTECH LABORATORIES INC TKINST68H 021510

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other