MAUDE Adverse Event Report: VITALCONNECT VITALPATCH BIOSENSOR; WIRELESS PHYSIOLOGICAL MONITOR, PRODUCT CODE:DRG

Model Number	3012-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ulceration (2116)
Date of Event	08/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned for analysis, and a visual inspection did not reveal any anomalies with the device.A review of the data provided by the customer indicated that the device was functional for its intended duration.A review of the manufacturing records did not identify any discrepancies that could be related to the reported issue.A review of manufacturing records identified that the same patient contacting adhesive lot has been used in the manufacture of (b)(4) lots for a total of (b)(4) devices.Additionally, the same lot of patient contact hydrogel has been used in (b)(4) lots dating back to may 2016 (date of device manufacture).The complaint files were reviewed and there has been one other report of a skin ulceration originating from the same customer using the same lot of devices.There have been no other similar complaints from other customers or for other device lots.The customer was asked to provide the labeling that accompanied the device in the investigational study, which was provided and reviewed.Upon review, it was identified that the customer generated instructions for device application are not consistent with the device manufacturer's instructions for use.More specifically, the customer instructs the use of cavilon no sting barrier film prior to the application of the device.None of the clinical wear validations conducted by the manufacturer have evaluated the device compatibility with cavilon.Based on this information, failure to follow instructions was identified as the root cause.
Event or Problem Description
Subject had applied the device on (b)(6) 2017 and in the evening started having a burning sensation, irritating the skin a little bit.The symptoms went away.Upon removal on (b)(6) 2017, the subject noticed that the area under the battery side was raw and had broken skin.The patient did not seek medical attention for this skin ulceration; the situation resolved on its own.

• Brand Name: VITALPATCH BIOSENSOR
• Common Device Name: WIRELESS PHYSIOLOGICAL MONITOR, PRODUCT CODE:DRG
• Manufacturer (Section D): VITALCONNECT; 224 airport parkway; suite 300; san jose CA 95110
• MDR Report Key: 6898653
• Report Number: 3010830833-2017-00002
• Device Sequence Number: 16495931
• Product Code: DRG
• UDI-Device Identifier: 00850490007146
• UDI-Public: 00850490007146
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K152139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/02/2017
• Device Model Number: 3012-01
• Device Catalogue Number: 3012-01
• Device Lot Number: 06117401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2017
• Initial Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other