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

Model Number 01-01

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

Patient Problems Unspecified Infection (1930); Local Reaction (2035); Ulcer (2274); Skin Inflammation (2443)

Event Date 08/12/2016

Event Type  Injury  

Manufacturer Narrative

The sterile aquasonic 100 technical data sheet (tds) was forwarded to the distributor for the physician.The distributor subsequently provided the doctor's contact information, and parker is following up directly with the physician for additional information, including: any additional information related to why the physician believes the gel may or may not have contributed to the event.Was any topical or other treatment provided to the patient directly following the event? any additional information available regarding the biopsy procedure, or any other procedures that may have been performed on this patent.Any other products that may have been used on the patient that may be related to the event.Details regarding the location and size of the skin reaction and the skin graft.Details of any allergy testing that may have been completed or is planned.Did the patient have any previously known allergies? details of the "drag" treatment that was provided to the patient.The batch record for the product involved in the event has been reviewed; all specifications were met at the time of manufacture.Product labeling was reviewed; the instructions for use include the following: "do not use on patients with a known sensitivity to parabens." parker has not received any related complaints where it was reported that sterile aquasonic 100 may have contributed to a skin graft; however, it is noted that topical skin reactions have been reported at a very low rate (< 0.02 skin reaction reports per estimated million procedures in the past six years).No other complaints have been reported for this lot.A supplemental medwatch report will be submitted if any further information is received.Device not available.

Event Description

Parker's distributor in (b)(4) initially reported that a patient had experienced an allergic reaction to sterile aquasonic 100 ultrasound transmission gel.During follow up communications with the distributor, it was determined that the patient had undergone a biopsy on their back using the gel, and one hour later, the area was red and inflamed.They reported that a "drag" treatment was performed on the patient, but their condition did not improve.Approximately two months later, skin grafting was performed.It was reported that it is suspected the grafting may be attributable to the gel, but it is not certain.This was the first time sterile aquasonic 100 had been used by the physician with this patient.

Manufacturer Narrative

Parker has received the following additional information from the patient's physician: on (b)(6) 2017 the physician reported that the patient is a (b)(6) year-old female.A renal biopsy was performed in (b)(6) 2016 (exact date not provided).The patient was discharged from the hospital the following day.A week later, she visited the hospital.The physician observed an ulcer and infection in the puncture of her back.The patient required skin grafting, which was performed by the plastic surgeon at the hospital where the renal biopsy was performed.Dlst allergy testing (drug-induced lymphocyte stimulation test) was performed for the products that were used during the biopsy.These products included sterile aquasonic 100, for which the patient tested positive.Parker followed up with the physician for additional details related to the event.On (b)(6) 2017, the physician provided the following information: the patient had been diagnosed with iga nephropathy during a renal biopsy that had been performed eight years earlier.The patient advised the physician that she may have experienced an infection at that time, but she did not remember the exact details of the prior biopsy.She did not have any known allergies or take any medicine prior to the initial event occurring.Regarding the (b)(6) 2016 event, an ultrasonic diagnosis of the kidney was performed the day prior to the renal biopsy.Sono-jelly gel was used at that time.During the renal biopsy, sono-jelly, sterile aquasonic 100, isodine for sterilization, and xylocaine were used.The patient was discharged from the hospital the day after the biopsy.A week later, the patient returned to the hospital, at which time the ulcer and infection were observed.She was treated with antibiotics, but the wound worsened.The wound size was about 3 cm, and the depth was about 1.5 cm at the time.The patient subsequently underwent debridement and skin grafting by the hospital's plastic surgeon; however, the condition of the wound worsened, which led hospital staff to believe that the patient may have displayed allergies to the materials used.Allergy testing (a drug-induced lymphocyte stimulation test or dlst) was performed for the products that were used during the biopsy.The patient tested positive for allergic reaction to sterile aquasonic 100.Specific results (stimulation indexes) are noted below.The physician indicated that results over 180 are considered positive: sterile aquasonic 100 (sterilized) = si 188.Sterile aquasonic 100 (not sterilized) = si 165.Sono-jelly = si 140.Xylocaine = si 77.The physician concluded that hospital staff could not determine if the use of sterile aquasonic 100 contributed to the event; however, they informed the patient of the test results and recommended that she avoid using the gel in the future.

• Brand Name: STERILE AQUASONIC 100
• Type of Device: ULTRASOUND TRANSMISSION GEL
• Manufacturer (Section D): PARKER LABORATORIES, INC.; 286 eldridge road; fairfield NJ 07004 9510
• Manufacturer (Section G): PARKER LABORATORIES, INC.; 286 eldridge road; fairfield NJ 07004 7261
• Manufacturer Contact: candy beck ; 286 eldridge road; fairfield, NJ 07004-7261 ; 9732769500
• MDR Report Key: 6722897
• MDR Text Key: 80379042
• Report Number: 2212018-2017-00001
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K802146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/11/2017

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: Physician
• Device Expiration Date: 03/31/2019
• Device Model Number: 01-01
• Device Catalogue Number: 01-01
• Device Lot Number: J1015002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/11/2017
• Initial Date FDA Received: 07/18/2017
• Supplement Dates Manufacturer Received: 07/11/2017
• Supplement Dates FDA Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 31 YR