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

Catalog Number UNKNOWN

Device Problems Nonstandard Device (1420); Biocompatibility (2886)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 06/06/2021

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 gel of the artic gel pad was more aggressive and caused serious skin damage on two different patients.Per policy the skin checks were done every 2 hours.One was on patient¿s breast of breast cancer survivor (passed away) and the other was on backside of the patient.Also inquired about steroid usage can lead to thin skin integrity and about pressors which can cause vasoconstriction and lead to same issue.Per additional information received on 10jun2021, tried to clarify if either patient were on pressors which would affect perfusion and lead to fragile skin, and inquired whether the icu unit started using a new product or changed the process in some way which may have led to the incidents.Also discovered patient who expired had breast cancer so incident that occurred happened over a breast implant which was not recommended.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Corrections: b, h.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.

Event Description

It was reported that the gel of the artic gel pad was more aggressive and caused serious skin damage on two different patients.Per policy the skin checks were done every 2 hours.One was on patient¿s breast of breast cancer survivor (passed away) and the other was on backside of the patient.Also inquired about steroid usage can lead to thin skin integrity and about pressors which can cause vasoconstriction and lead to same issue.Per additional information received on 10jun2021, representative tried to clarify if either patient were on pressors which would affect perfusion and lead to fragile skin, and inquired whether the icu unit started using a new product or changed the process in some way which may have led to the incidents.It was also discovered that, patient who expired had breast cancer so incident that occurred happened over a breast implant which was not recommended.No medical intervention was reported.Clinical follow ups were attempted on 08jul2021 and 09jul2021 with no response received.There was no indication that the device contributed to the patient's death.Despite good faith efforts no additional information has been obtained.

Event Description

It was reported that the gel of the artic gel pad was more aggressive and caused serious skin damage on two different patients.Per policy the skin checks were done every 2 hours.One was on patient¿s breast of breast cancer survivor (passed away) and the other was on backside of the patient.Also inquired about steroid usage can lead to thin skin integrity and about pressors which can cause vasoconstriction and lead to same issue.Per additional information received on 10jun2021, representative tried to clarify if either patient were on pressors which would affect perfusion and lead to fragile skin, and inquired whether the icu unit started using a new product or changed the process in some way which may have led to the incidents.It was also discovered that, patient who expired had breast cancer so incident that occurred happened over a breast implant which was not recommended.No medical intervention was reported.Clinical follow ups were attempted on (b)(6) 2021 and (b)(6) 2021 with no response received.There was no indication that the device contributed to the patient's death.Despite good faith efforts no additional information has been obtained.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿4.2.1 material selection - surface roughness, adhesive strength¿.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.The dhr review could not be performed without a lot number.The product catalog number and lot number for this device is unknown.Therefore, bd is 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
• MDR Report Key: 12080577
• MDR Text Key: 258903948
• Report Number: 1018233-2021-03851
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other