MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL; TEMPERATURE THERAPY BLANKET

Model Number T5080NS

Device Problem Improper Flow or Infusion (2954)

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

Event Date 03/01/2016

Event Type  malfunction  

Manufacturer Narrative

Two complaints (deroyal ref.No.(b)(4)) were filed together from the same user facility ((b)(4)) for products with the same part number (t5080ns - cold therapy blanket) each reporting the same adverse event.A medical device report (mdr) is being filed for each.(b)(4) is reported under mdr no.2320762-2016-00002 (this report).(b)(4) is reported under mdr no.2320762-2016-00003.Investigation findings: determining possible lot number of product reported in complaint.The user facility reported that the complaint sample was discarded and lot number was not recorded.Therefore neither of these were available for review.The assigned deroyal investigator performed a shipping inquiry by the customer number and the finished good part number that the complaint is filed for.This search showed that the customer had received the same lot number on their last two orders.That lot number is 38249215.Through that search, it was determined that the lot number in question is more than likely 38249215.Testing of product from lot suspected to be same as complaint in distribution center.Since the complaint sample was not available, an available sample from suspected lot was tested.Testing was performed by following the instructions for use.The sample was attached the to a corresponding cold therapy unit filled with ice and water.The unit was allowed to run for approximately five minutes.During this time, the blanket was manipulated so as to try and duplicate the customer's report.This manipulation consisted of pressing on the blanket in various areas, twisting the blanket and even standing on it.None of these things caused the blanket to pop, or to even leak.The customer's report could not be duplicated with the sample product tested.Misuse of product by the customer.The customer reported performing two actions that go against warnings in the instructions for use (ifu).The initial report given to deroyal by the user facility stated that "when the surgeon puts the product on the patient after surgery under the partial cast the product popped and the cast became wet from the water".Our ifu has a warning that states "do not apply therapy blanket underneath a fiberglass or plaster cast or other dressing, wrapping or bracing that would prevent the patient from checking the skin under the therapy blanket." a follow up inquiry with the customer found that the user facility used a competitor temperature therapy unit with the deroyal temperature therapy blanket in question.The competitor unit used was the polar care cube by breg.The customer also stated that they use deroyal blankets with this unit all the time.Our ifu has a warning that states "do not use this therapy blanket with any unit other than a deroyal brand unit." the deroyal temperature therapy blankets are specifically designed and optimized to work with their corresponding deroyal temperature therapy unit.Root cause: the deroyal investigator was unable to duplicate the reported failure with a new part from the suspected lot.In addition, the customer did not follow the warnings in the ifu of using the product with a competitor unit.The deroyal temperature therapy blankets are specifically designed and optimized to work with their corresponding deroyal temperature therapy unit.Based on this information, it is concluded that customer misuse potentially caused the reported product failure.Corrections: no corrections were necessary.Corrective action: the potential root cause was customer misuse.There is no corrective action necessary at this time.Preventive action: the potential root cause was customer misuse.There is no preventive action necessary at this time.No further information is available at this time.We will provide follow up report if additional information becomes available.

Event Description

Copied below are responses given by the initial reporter to the deroyal complaint questionnaire.Questionnaire start: when did quality issue occur? during use.Who was using or operating the product when the quality issue occurred? patient/end consumer.Was a medical procedure involved? no.Name of medical procedure: not applicable.Did the quality issue cause a delay in the medical procedure? not applicable.Detailed description of quality issue: when the surgeon puts the product on the patient after surgery under the partial cast the product popped and the cast became wet from the water - the product was discarded so the customer does not have the lot numbers or the product to return.How was the quality issue was identified? by actual use.How was the product being used? as recommended.Was it the initial use of the product? yes.Was the product modified from the original condition supplied by deroyal? no.Was the product connected to or used in conjunction with other devices or equipment? no.Outcome(s) attributed to quality issue: none.Person(s) affected by outcome(s) checked above: none.Known pre-existing condition(s) of person(s) affected: n/a.Was the incident reported to the fda? don't know.Detailed description of outcome(s), including information regarding injury or any additional treatment/intervention required: no injury reported.Questionnaire end.The investigation team followed up the initial report with additional questions.The questions and corresponding answers are copied below: was the blanket in question being used with a deroyal t505 temperature therapy unit or was it being used with a competitor unit? the blanket was being used with a polar care cube by breg.Customer stated they use deroyal blankets with this unit all the time.Was there a wound that got wet? surgery was performed and the blanket was put on after surgery.Did the cast have to be replaced? the cast had to be replaced.

• Brand Name: DEROYAL
• Type of Device: TEMPERATURE THERAPY BLANKET
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1595 hwy 33 south; new tazewell TN 37825
• Manufacturer Contact: marian vargas ; 200 debusk ln; powell 37849 ; 8653621013
• MDR Report Key: 5492460
• MDR Text Key: 40328983
• Report Number: 2320762-2016-00002
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2016,03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: T5080NS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 03/01/2016
• Date Manufacturer Received: 03/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other