MAUDE Adverse Event Report: AMBU A/S AMBU BLUE SENSOR VLC

Catalog Number VLC-00-S/25

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Itching Sensation (1943); Swelling (2091); Burning Sensation (2146); Reaction (2414)

Event Date 04/16/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The affected electrodes was not received for investigation, neither was lot number of the affected items or photos of patient's reactions.Due to limited information, it is difficult to verify the reported failure and the root cause of the reported failure cannot be identified.It has not been possible to obtain further information.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.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

Six day monitor put on (b)(6) 2016 at 2.30pm.On (b)(6) 2016 patient felt tingly feeling directly under the electrode.On (b)(6) 2016 5.10 am patient felt like skin was on fire.Took everything off.Splashed cool water on site - site had blistered and continuously burning.At 9 am, body had hives.Patient went to chemist for a consultation, who confirmed that the reaction was not due to medication.Patient took an antihistamine.Patients face went blood red, lips and throat itchy and sore, feet swollen, breathing issue.Patient went to emergency room and was subsequently admitted to the hospital.Prednisolone 5 mg and antihistamine was given in emergency room and continue for 2 days.

• Brand Name: AMBU BLUE SENSOR VLC
• Type of Device: BLUE SENSOR VLC
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; 2750 ballerup, 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: 6100328
• MDR Text Key: 59813798
• Report Number: 9610691-2016-00005
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: D194483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VLC-00-S/25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 49 YR
• Patient Weight: 75