Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS Back to Search Results
Device Problem Biocompatibility (2886)
Patient Problem Burning Sensation (2146)
Event Date 05/17/2021
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that the arctic sun gel pads to burn a patient's skin.It was explained that prolonged exposure to extreme water temperature could cause skin damage or burns.The machine had alerts or alarms to notify the clinician when this happens.It was asked if this was an issue in facility.It was stated that the patient started therapy on (b)(6) 2021, and qa received the incident report on (b)(6) 2021.The patient had burning on abdominal area that required debridement and packing.They had no other information at this time but would work on obtaining it.The user would call with the machine and a usb drive so that they could review the data file.They would also like to arrange training/education for the department (hypothermia - post ca).Per follow up on (b)(6) 2021 via nurse, the condition of skin was intact before the pads were applied.Nothing was placed on the skin before the pads were applied.The patients right lower abdomen, size was significant, 6 cm by 13 and in surgery, it was much larger.The area looked like necrotic.They receive medical treatment for that area, in surgery it was debrided.Woc was consulted on day of event.Q4 hour and did not look under pads when inspecting.Patient had cardiac arrest and heart disease.The pads were not placed over any incision or bony surfaces.Pads were disposed of.The patient able to complete therapy on the device.
 
Manufacturer Narrative
The reported event was inconclusive because no sample was returned.It was unknown whether the device had met relevant specifications.The product was used for diagnostic purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be ¿materials that are contacting the patient¿s intact skin are not bio compatible ¿.The lot number was unknown; therefore, the device history record could not be reviewed.The product catalog number and lot number for this device was unknown.Therefore, bd was unable to determine the associated labeling to review.H11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.
 
Event Description
It was reported that the arctic sun gel pads to burn a patient's skin.It was explained that prolonged exposure to extreme water temperature could cause skin damage or burns.The machine had alerts or alarms to notify the clinician when this happens.It was asked if this was an issue in facility.It was stated that the patient started therapy on (b)(6) 2021, and qa received the incident report on (b)(6) 2021.The patient had burning on abdominal area that required debridement and packing.They had no other information at this time but would work on obtaining it.The user would call with the machine and a usb drive so that they could review the data file.They would also like to arrange training/education for the department (hypothermia - post ca).Per follow up on (b)(6) 2021 via nurse, the condition of skin was intact before the pads were applied.Nothing was placed on the skin before the pads were applied.The patients right lower abdomen, size was significant, 6 cm by 13 and in surgery, it was much larger.The area looked like necrotic.They receive medical treatment for that area, in surgery it was debrided.Woc was consulted on day of event.Q4 hour and did not look under pads when inspecting.Patient had cardiac arrest and heart disease.The pads were not placed over any incision or bony surfaces.Pads were disposed of.The patient able to complete therapy on the device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNKNOWN ARCTICGEL PADS
Type of Device
UNKNOWN ARCTICGEL PADS
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
MDR Report Key11971666
MDR Text Key256450193
Report Number1018233-2021-03374
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup
Report Date 08/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received08/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-