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

Catalog Number UNKNOWN

Device Problem Nonstandard Device (1420)

Patient Problems Skin Discoloration (2074); Blister (4537)

Event Date 07/27/2021

Event Type  malfunction  

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 gel pads were particularly difficult to remove.While removing the arctic gel pads, two blisters and a red area were noticed.Two blisters were appeared on the right hip and thigh.The patient had a particularly large area of redness developed where the abdomen was resting on the lines of the left thigh pad.It was stated that the therapy had been completed.Per follow up via ibc on (b)(6) 2021, the nurse described the arctic gel pads were being difficult to remove due to the stickiness.This issue was identified during discussions in a training session.It was stated they did not have any details regarding lot numbers for the arctic gel pads, the unit has two arctic sun machines, serial numbers were provided, but they were not able to tell which machine was used.It was stated the patient was particularly large, so the product code for the arctic gel pads would be 31709 or 3170902 if the pads were from a double pack.No medical intervention was reported.

Event Description

It was reported that the arctic gel pads were particularly difficult to remove.While removing the arctic gel pads, two blisters and a red area were noticed.Two blisters were appeared on the right hip and thigh.The patient had a particularly large area of redness developed where the abdomen was resting on the lines of the left thigh pad.It was stated that the therapy had been completed.Per follow up via ibc on 28jul2021, the nurse described the arctic gel pads were being difficult to remove due to the stickiness.This issue was identified during discussions in a training session.It was stated they did not have any details regarding lot numbers for the arctic gel pads, the unit has two arctic sun machines, serial numbers were provided, but they were not able to tell which machine was used.It was stated the patient was particularly large, so the product code for the arctic gel pads would be 31709 or 3170902 if the pads were from a double pack.No medical intervention was reported.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.It is 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 ¿4.2.1 material selection - surface roughness, adhesive strength¿.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 arcticgel pads ifus are found to be adequate based on past reviews.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.

• 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
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12360173
• MDR Text Key: 267889585
• Report Number: 1018233-2021-05140
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2022
• 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