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.Complaint (b)(4) is reported under mdr no.2320762-2016-00002.Complaint (b)(4) is reported under mdr no.2320762-2016-00003 (this report).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).A) 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." b) 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 (b)(4).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.A copy of the ifu with sections of interest highlighted in yellow is attached.File name "ifu 43-00409n rev1-15 temp therapy blanket".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.
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