MAUDE Adverse Event Report: PARKER LABORATORIES, INC. STERILE AQUASONIC 100; ULTRASOUND TRANSMISSION GEL

Model Number 01-01-4

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

Patient Problems Anaphylactoid (2218); Urticaria (2278)

Event Date 11/22/2016

Event Type  Injury  

Manufacturer Narrative

We are continuing to follow up with the physician for allergic testing results.A supplemental medwatch will be submitted when additional information is received.Device not available.

Event Description

Parker laboratories was contacted by an allergist who reported that a patient receiving a central venous catheter experienced anaphylaxis.Sterile aquasonic 100 ultrasound transmission gel had been used on the patient during an echocardiogram about 45 minutes before the reaction took place.Within one or two minutes after the introduction of the line, the patient said he was itchy, and developed urticaria all over his body.Within 2 minutes he was in full anaphylactic shock requiring adrenalin, clemastine, and steroids.He needed the adrenaline iv for some hours; he was sedated and intubated.The allergist requested that parker provide a list of the ingredients of the gel to exclude all possible allergenic sources for the reaction.The list was provided.During follow up emails, the allergist advised that she does not have the lot number of the product involved in the event, as the packaging had already been discarded.The gel appeared to have normal color, odor, and appearance at the time of application.Previously known allergies for the patient include apple and kiwi.The allergist advised that in addition to the gel, she also considered potential sources of the reaction to be chlorhexidine, ethylene oxide, latex, iodine, and peg (since the patient was dialysis dependent for some years prior to the event).On (b)(6) 2016, the day following the event, the patient was still intubated and sedated.On november 30, 2016 the allergist provided the following update: the patient is doing well.Chlorhexidine is the prime suspect at this time because a radioallergosorbent (rast) has returned a positive result for this medicine.She plans to have the patient return to her office to evaluate all other possible causes for the reaction.As of december 14, 2016, the allergist advised that the testing had not been completed and no additional information was available.

Manufacturer Narrative

On february 19, 2017 the allergist advised that the patient did not come in for scheduled testing on (b)(6) 2017 and has not responded to her follow up phone calls.Therefore, no further information is available related to this report.As previously noted, the allergist does not believe that the sterile aquasonic® 100 that was used 45 minutes prior to the event caused the allergic reaction.The patient tested positive for allergic response to chlorhexidine, and their response occurred within one to two minutes after the chlorhexidine was introduced.Parker is not aware of any related events.

Event Description

• Brand Name: STERILE AQUASONIC 100
• Type of Device: ULTRASOUND TRANSMISSION GEL
• Manufacturer (Section D): PARKER LABORATORIES, INC.; 286 eldridge road; fairfield NJ 07004 7261
• Manufacturer (Section G): PARKER LABORATORIES, INC.; 286 eldridge road; fairfield NJ 07004 7261
• Manufacturer Contact: candy beck ; 286 eldridge road; fairfield, NJ 07456-7261 ; 9732769500
• MDR Report Key: 6211167
• MDR Text Key: 63476296
• Report Number: 2212018-2016-00001
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 20855683006023
• UDI-Public: 20855683006023
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K802146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Radiologic Technologist
• Device Model Number: 01-01-4
• Device Catalogue Number: 01-01-4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2017
• 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
• Treatment: CHLORHEXIDINE, ETHYLENE OXIDE, LATEX, IODINE, PEG
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 27 YR