MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTIC GEL PAD

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Skin Discoloration (2074); Pressure Sores (2326); Blister (4537); Skin Inflammation/ Irritation (4545); Unspecified Tissue Injury (4559)

Event Date 03/09/2022

Event Type  Injury  

Event Description

It was reported that the patient had some blisters under breasts due to the use of arctic gel pads.Per follow-up information received from ibc on 30mar2022, stated that on (b)(6) 2021, the underside of both breasts had been excoriated and red, clotrimazole had been applied.The area's under the breasts had also been broken down further but currently there was granulation here and they would consider the area's to be grade 2 pd.Dressings had been applied.On (b)(6) 2022, patient was receiving active cooling treatment (arctic sun).The equipment the patient was wearing caused injury below their right breast.Equipment position altered.Gauze placed across area to minimise effects of pressure.Nurse in charge was informed and incident was investigated.Although noted that the arctic sun pads had caused a blister, it was noted that in the days running up to the incident it had been reported in the patient's nursing notes that they had severe moisture lesions and sore, friable skin under the breasts already.The patient had an ulcer under their breast that was though to be possibly due to the pads for the arctic sun machine being used to cool the patient.Reading the notes, the user stated that it was clear that the patient was already suffering from broken/ sore skin in this area in the days leading up to the incident.It was unlikely that the equipment alone caused the damage to the patient's skin.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.It is unknown whether the device had met relevant specifications.The product was used for diagnostic and treatment 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 biocompatible¿.The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labelling review due to unknown product code.Although the product family was unknown, the arctic gel pad product ifus were found to be adequate based on past reviews.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 patient had some blisters under breasts due to the use of arctic gel pads.Per follow-up information received from ibc on 30mar2022, stated that on (b)(6) 2021, the underside of both breasts had been excoriated and red, clotrimazole had been applied.The area's under the breasts had also been broken down further but currently there was granulation here and they would consider the area's to be grade 2 pd.Dressings had been applied.On (b)(6) 2022, patient was receiving active cooling treatment (arctic sun).The equipment the patient was wearing caused injury below their right breast.Equipment position altered.Gauze placed across area to minimise effects of pressure.Nurse in charge was informed and incident was investigated.Although noted that the arctic sun pads had caused a blister, it was noted that in the days running up to the incident it had been reported in the patient's nursing notes that they had severe moisture lesions and sore, friable skin under the breasts already.The patient had an ulcer under their breast that was though to be possibly due to the pads for the arctic sun machine being used to cool the patient.Reading the notes, the user stated that it was clear that the patient was already suffering from broken/ sore skin in this area in the days leading up to the incident.It was unlikely that the equipment alone caused the damage to the patient's skin.

• Brand Name: UNKNOWN ARCTIC GEL PAD
• Type of Device: UNKNOWN ARCTIC GEL PAD
• 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: 14212350
• MDR Text Key: 290104567
• Report Number: 1018233-2022-03007
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• 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: 07/19/2022
• 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): Required Intervention