MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTICGEL PADS; ARCTIC SUN GEL PAD

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burning Sensation (2146); No Consequences Or Impact To Patient (2199)

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 sun device was on a patient during an intrepid study when the patient felt as if the pads were burning him.The pads were removed and therapy was discontinued.

Event Description

It was reported that the arctic sun device was on a patient during an intrepid study when the patient felt as if the pads were burning him.The pads were removed and therapy was discontinued.

Manufacturer Narrative

The device was not returned for evaluation.A potential failure mode could be bio-incompatible effect 1: skin damage¿ with a potential root cause of '8.1.2 materials that are contacting the patient's intact skin are not biocompatible the lot number is unknown therefore the device history record could not be reviewed.The product code for the unknown arcticgel pads product is unknown.Therefore, bd is unable to determine the associated labeling to review.Although the product code is unknown, the z300 unknown arcticgel pads product labeling is found to be adequate based on past reviews.

• Brand Name: ARCTICGEL PADS
• Type of Device: ARCTIC SUN GEL PAD
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 9107544
• MDR Text Key: 165230091
• Report Number: 1018233-2019-05869
• 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: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Weight: 125