MAUDE Adverse Event Report: CELESTICA ELECTRONICS S PTE LTD BIS; ELECTRODE, CUTANEOUS

Model Number 186-0106

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Skin Discoloration (2074)

Event Date 02/08/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, after the device was remove from the forehead patient had skin irritations.There was patient harm associated with this event.

• Brand Name: BIS
• Type of Device: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): CELESTICA ELECTRONICS S PTE LTD; no. 6 serangoon north avenue 5; singapore 55491 0; SN 554910
• Manufacturer (Section G): CELESTICA ELECTRONICS S PTE LTD; no. 6 serangoon north avenue 5; singapore 55491 0; SN 554910
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 11802368
• MDR Text Key: 249978643
• Report Number: 2936999-2021-00421
• Device Sequence Number: 1
• Product Code: GXY
• UDI-Device Identifier: 20884521134307
• UDI-Public: 20884521134307
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093183
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186-0106
• Device Catalogue Number: 186-0106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2021
• 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: 39 YR
• Patient Weight: 124