MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 ARTICGEL PADS; ARCTIC SUN PADS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Stroke/CVA (1770); Edema (1820); Inflammation (1932); Necrosis (1971); Rash (2033); Sepsis (2067); Tissue Damage (2104); Toxic Shock Syndrome (2108); Skin Tears (2516)

Event Date 05/10/2017

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device was not returned.

Event Description

It was reported that a patient experienced skin peeling after receiving therapy on the arctic sun device.The skin was peeling on the thighs and abdomen when the pads were removed.There was also skin peeling on the arms and hands where the pads were not placed.Mepelex ag silver sheets were applied to the skin.Therapy was initiated for fever suppression.The patient had an autoimmune inflammatory disorder and acute exacerbation upon admission.The skin team was consulted before arctic sun therapy was initiated, due to the spreading purpuric rash related to critical thrombocytopenia on the abdomen and thighs.The patient was in fulminant sepsis requiring triple vasopressor therapy for hypotensive toxic shock at the time of arctic sun therapy.Therapy began on (b)(6) 2017 and continued until (b)(6) 2017 for 32 hours and 28 minutes.Therapy was discontinued for approximately one hour, so the patient could undergo a computerized tomography (ct) scan.Therapy was again initiated on (b)(6) 2017, and continued until later that day for 11 hours and 56 minutes.The patient was on the arctic sun device with serial number (b)(4).The patient was admitted on (b)(6) 2017 for stroke with hemorrhagic conversion, as a confirmed by the admitting physician.There was a vascath placed in the right groin area on the patient for continuous renal replacement therapy on an unknown date.The patient experienced toxic shock syndrome with, super (b)(4) sepsis in the blood on (b)(6) 2017.The cooling methods used prior to arctic sun treatment included a bair hugger and a gaymar cooling blanket.The patient received paralytics and versed for shivering.The patient also presented with left arm gross edema, consistent with necrosis and digit loss of fingers and toes.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.Although the product family is unknown, the artic gel pad product ifus are found to be adequate based on past reviews.(b)(4).

Event Description

It was reported that a patient experienced skin peeling after receiving therapy on the arctic sun device.The skin was peeling on the thighs and abdomen when the pads were removed.There was also skin peeling on the arms and hands where the pads were not placed.Mepelex ag silver sheets were applied to the skin.Therapy was initiated for fever suppression.The patient had an autoimmune inflammatory disorder and acute exacerbation upon admission.The skin team was consulted before arctic sun therapy was initiated, due to the spreading purpuric rash related to critical thrombocytopenia on the abdomen and thighs.The patient was in fulminant sepsis requiring triple vasopressor therapy for hypotensive toxic shock at the time of arctic sun therapy.Therapy began on (b)(6) 2017 and continued until (b)(6) 2017 for 32 hours and 28 minutes.Therapy was discontinued for approximately one hour, so the patient could undergo a computerized tomography (ct) scan.Therapy was again initiated on (b)(6) 2017, and continued until later that day for 11 hours and 56 minutes.The patient was on the arctic sun device with serial number (b)(4).The patient was admitted on (b)(6) 2017 for stroke with hemorrhagic conversion, as a confirmed by the admitting physician.There was a vascath placed in the right groin area on the patient for continuous renal replacement therapy on an unknown date.The patient experienced toxic shock syndrome with, super (b)(6)in the blood on (b)(6) 2017.The cooling methods used prior to arctic sun treatment included a bair hugger and a gaymar cooling blanket.The patient received paralytics and versed for shivering.The patient also presented with left arm gross edema, consistent with necrosis and digit loss of fingers and toes.

• Brand Name: ARTICGEL PADS
• Type of Device: ARCTIC SUN PADS
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6614802
• MDR Text Key: 76765651
• Report Number: 1018233-2017-02938
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2017
• 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): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 105