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

Model Number 01-50

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

Patient Problems Dysphagia/ Odynophagia (1815); Local Reaction (2035); Respiratory Distress (2045); Skin Inflammation (2443)

Event Date 12/19/2014

Event Type  Injury  

Event Description

A pt contacted parker laboratories' authorized rep in the (b)(6) and reported the following: pt rec'd a sonogram of the heart where the ultrasound gel from parker was involved.About 30 minutes after this check up she noticed that the skin in this area was red and itchy.In order to alleviate the symptoms she put on some thin lotion ((b)(6)) on this area.Unfortunately, this did not help.Because of this she removed the lotion with water and put on fenistil hydrocort on this area.The redness and itching was still there and becomes bigger and bigger on the skin.Next day she went to the dermatologist which prescribed cortisone creme.This did also not help and in addition she got hot redness, itch and bright quad spindles all over her whole body.At the end she got shortness of breath and difficulty in swallowing.Therefore, she was brought to the (b)(6) hospital in (b)(6).The physicians gave her antihistamines against these reactions.This treatment helped slowly and it healed up until today.The pt is according to her statement multimorbid because she is a stroke pt and has a knee endoprosthesis.

Manufacturer Narrative

The device history record for the reported prod batch was reviewed; it was confirmed that spec had been met at the time of mfg.The ingredient list was provided for reference by the pt's physician prior to a scheduled but unrelated surgery.We are following up for add'l info including; any prior known allergies for this pt, results of any skin patch testing that may have been performed, had the pt been exposed to the get in the past and if so, was there a reaction, pt age/dob, and weight.We have also requested an opportunity to evaluate the get that was used at the time of the event; however, it may have been consumed by the time (b)(6) was made aware of the event.The aquasonic 100 instructions for use include the following: contraindication: pts with immunodefficiency or immunosuppressive therapy.Warning: do not use on pt with a known sensitivity to parabens.The pt's husband has advised that she is currently hospitalized as a result of her unrelated surgery.A supplemental medwatch will be submitted if add'l info becomes available.Our ref: (b)(4).

• Brand Name: AQUASONIC 100
• Type of Device: ULTRASOUND TRANSMISSION GEL
• Manufacturer (Section D): PARKER LABORATORIES, INC.; fairfield NJ
• Manufacturer Contact: kathleen tirch, mgr ; 286 eldridge rd.; fairfield, NJ 07004 ; 9732769500
• MDR Report Key: 4645770
• MDR Text Key: 5756488
• Report Number: 2212018-2015-00001
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K802146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: 01-50
• Device Catalogue Number: 01-50
• Device Lot Number: H1044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention