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

Catalog Number 317-03-02

Device Problems Failure To Adhere Or Bond (1031); Device Slipped (1584)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 hydrogel on the pads were insufficient as they would not stick to the patient.

Event Description

It was reported that the hydrogel on the pads were insufficient, as they would not stick to the patient.

Manufacturer Narrative

The reported issue (it was reported that the hydrogel on the pads was insufficient and would not stick to the patient.) was confirmed, as cause unknown.During visual inspection it was noted that the pads did not have a hydrogel film covering it however, there were spots of hydrogel present through out the pad.No other discrepancies were found on the sample returned.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: ¿- use pads immediately after opening.Do not store pads in opened pouch.-periodically check that pads remain moist and adherent.Replace pads when the hydrogel no longer uniformly adheres to the skin.Replacing pads at least every 5 days is recommended." corrections: patient identifier, relevant tests/laboratory data,and other relevant history.

• Brand Name: ARTICGEL PADS
• Type of Device: ARCTICGEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 7266231
• MDR Text Key: 100147309
• Report Number: 1018233-2018-00432
• 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: company representative,other
• Type of Report: Initial,Followup
• Report Date: 05/17/2018

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 Expiration Date: 02/28/2018
• Device Catalogue Number: 317-03-02
• Device Lot Number: NGBP0392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Initial Date Manufacturer Received: 01/23/2018
• Initial Date FDA Received: 02/13/2018
• Supplement Dates Manufacturer Received: 05/10/2018
• Supplement Dates FDA Received: 05/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1