MAUDE Adverse Event Report: JABIL CIRCUIT SINGAPORE PTE LTD BIS; ELECTRODE, CUTANEOUS

Model Number 186-0106

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Skin Irritation (2076)

Event Date 07/09/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, post-operatively the patient reported redness, itching and swelling where the sensor had been placed during operation.Reported intervention was the use of hydrocortisone and urea cream.

• Brand Name: BIS
• Type of Device: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): JABIL CIRCUIT SINGAPORE PTE LTD; 16 tampines crescent; singapore 52860 4; SG 528604
• Manufacturer (Section G): JABIL CIRCUIT SINGAPORE PTE LTD; 16 tampines crescent; singapore 52860 4; SG 528604
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 10452651
• MDR Text Key: 204864028
• Report Number: 2936999-2020-00626
• Device Sequence Number: 1
• Product Code: GXY
• UDI-Device Identifier: 20884521134307
• UDI-Public: 20884521134307
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K093183
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/26/2020

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: 05/15/2014
• Device Model Number: 186-0106
• Device Catalogue Number: 186-0106
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 08/26/2020
• 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 Age: 26 YR
• Patient Weight: 110