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

Catalog Number UNKNOWN

Device Problem Nonstandard Device (1420)

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.The device was not returned.

Event Description

It was reported that the adhesive of the artic gel pad was more aggressive and there was skin damage on two different patients.Per facility policy, skin checks were performed every 2 hours.One of the incidents involved a breast cancer patient who passed away and the other incident was on the back side of another patient.Per additional information received on (b)(6) 2021, rep 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.Rep also discovered the patient who expired had breast cancer so one incident that occurred happened over a breast implant which was not recommended.No medical intervention 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.

Manufacturer Narrative

The reported event was inconclusive as no sample returned for evaluation.A potential root cause for this failure mode could be due to the material selection or surface roughness or adhesive strength.It was 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 device was not returned for evaluation.The lot number was unknown therefore the device history record could not be reviewed.The product catalog number and lot number for this device was unknown.Therefore bd was unable to determine the associated labeling to review.Correction: d, e 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 adhesive on the artic gel pad was more aggressive and there was skin damage on two different patients.Per facility policy the skin checks were performed for every 2 hours.One of the incidents involved a breast cancer patient who passed away and the other incident was on the back side of another patient.Per additional information received on (b)(6) 2021 the representative tried to clarify whether the patient was on pressors which would affect the perfusion and lead to fragile skin and inquired whether the intensive care unit (icu) started using a new product or changed the process in some way which may lead to the incidents.The representative also discovered the patient who expired had a breast cancer so one incident that occurred happened after a breast implant which was not recommended.No medical intervention reported.Per clinical follow ups attempted on (b)(6) 2021 and (b)(6) 2021 with no response received.There was no indication that the device contributed to the patients death.

• 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: 12372100
• MDR Text Key: 268304592
• Report Number: 1018233-2021-05214
• 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): Y
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 08/03/2021
• Initial Date FDA Received: 08/26/2021
• Supplement Dates Manufacturer Received: 09/01/2021
• Supplement Dates FDA Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other