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

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pressure Sores (2326)

Event Date 04/28/2022

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 the patient experienced grade 1 pressure damage due to the arctic gel pads.While looking at the area it looked like a long pinch.It was stated that the patient had significant large breast which they believed were the contributory factor.This looked like a user error during pad placement.

Event Description

It was reported that the patient experienced grade 1 pressure damage due to the arctic gel pads.While looking at the area it looked like a long pinch.It was stated that the patient had significant large breast which they believed were the contributory factor.This looked like a user error during pad placement.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿materials that are contacting the patient¿s intact skin are not biocompatible¿.The lot number was unknown; therefore, the device history record could not be reviewed.The product catalog number and the lot number for this device were unknown.Therefore, bd was unable to determine the associated labeling to review.H11: section a through f - 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.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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14453955
• MDR Text Key: 292174935
• Report Number: 1018233-2022-03929
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• 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: 07/30/2022
• 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