MAUDE Adverse Event Report: JABIL CIRCUIT(SHANGHAI) LTD BIS; ELECTRODE, CUTANEOUS

Model Number 186-0106

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Skin Inflammation (2443)

Event Date 05/09/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, after the procedure was completed, when the sensor was removed, burn-like symptom was seen that the patient's skin was whitish and swollen.After several hours of observation, the patient skin condition was not improved and the redness of the skin injury was not relieved.

• Brand Name: BIS
• Type of Device: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): JABIL CIRCUIT(SHANGHAI) LTD; no 600 tian lin rd; shanghai 20023 ; CN 20023
• Manufacturer (Section G): JABIL CIRCUIT(SHANGHAI) LTD; no 600 tian lin rd; shanghai 20023 ; CN 20023
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 8652509
• MDR Text Key: 146462545
• Report Number: 2936999-2019-00375
• Device Sequence Number: 1
• Product Code: GXY
• UDI-Device Identifier: 20884521134307
• UDI-Public: 20884521134307
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: 186-0106 BIS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/29/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2014
• Device Model Number: 186-0106
• Device Catalogue Number: 186-0106
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/09/2019
• Initial Date FDA Received: 05/29/2019
• 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): Other