MAUDE Adverse Event Report: AMBU A/S AMBU WHITESENSOR WS; ECG ELECTRODES

Catalog Number WS-00-S/3

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 11/07/2016

Event Type  Injury  

Manufacturer Narrative

The affected device was not returned for investigation.Investigation was done on retention samples of lot no.13516s5m3a, a review of device history record was also done and raw material inspection record was also reviewed.No nonconformities was noticed.If device is returned and if we find the cause other than listed below, we will submit follow up report.Biocompatibility testing of the electrodes is a requirement of the international organization for standardization (iso) 10993 - biological evaluation of medical devices.The tests required for surface electrodes are: sensitization study to evaluate the potential of the electrode to cause delayed dermal contact sensitization.Cytotoxicity study (in vitro) to determine the electrode's potential of causing cell death.· primary skin irritation to evaluate whether the topical application of the electrode can cause skin irritation.Device has passed biocompatibility testing.On the basis above investigation finding, no root cause was identified that have caused the problem of skin allergy.Despite ambu electrodes being developed and tested to assure that the materials are biocompatible, it is not possible to guarantee that no patients can eventually react to a certain substance contained in the gel or medical adhesive.

Event Description

Patient had allergic skin reaction at the area of the gel of the electrode.Patient was treated in er and doing fine now.

• Brand Name: AMBU WHITESENSOR WS
• Type of Device: ECG ELECTRODES
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• Manufacturer (Section G): AMBU INC.; 6230 old dobbin lane; suite 250; columbia MD 21045
• Manufacturer Contact: sanjay parikh ; 6230 old dobbin lane; suite 250; columbia, MD 21045 ; 4107686464
• MDR Report Key: 6149168
• MDR Text Key: 61561030
• Report Number: 9610691-2016-00008
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D150378
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: WS-00-S/3
• Device Lot Number: 13516S5M3A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2016
• Initial Date FDA Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 50 YR
• Patient Weight: 75