MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS

Device Problem Biocompatibility (2886)

Patient Problems Peeling (1999); Injury (2348)

Event Date 11/25/2020

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that during removal of the arctic sun gel pads after the patient's death, some of the patient¿s skin was damaged.The patient was an elderly female with very thin parchment-like skin and poor tissue perfusion.Per information provided upon receipt of the complaint, the patient died due to cardiac arrest.A follow up has been requested by the (b)(6) clinical team for additional information.Per additional information received on 08jan2021, the patient was placed on the device for treatment after a cardiac arrest.The patient was on the device from 2:41pm to 4:33 pm.The skin of the patient was described as "parchment skin" prior to placement of the pads.It was not known how long after the patient's death the pads were removed.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿hydrogel promotes bacterial growth on patient¿s skin¿.The lot number is unknown; therefore, the device history record could not be reviewed.The product catalog number and the lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.H11: section a through f - the information provided by bd represents all 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 during removal of the arctic sun gel pads after the patient's death, the patient¿s skin was damaged.The patient was an elderly female with very thin parchment-like skin and poor tissue perfusion.Per information provided upon receipt of the complaint, the patient died due to cardiac arrest.A follow up has been requested by the ucc clinical team for additional information.Per additional information received on 08jan2021, the patient was placed on the device for treatment after a cardiac arrest.The patient was on the device from 2:41pm to 4:33 pm.The skin of the patient was described as "parchment skin" prior to placement of the pads.It was not known how long after the patient's death the pads were removed.

• 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 Key: 11153529
• MDR Text Key: 226234224
• Report Number: 1018233-2020-22440
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other