MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; JELLY,LUBE,STERILE,FLIP TOP,TUBE,4-OZ

Model Number MDS032290

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 02/11/2020

Event Type  Injury  

Manufacturer Narrative

According to the customer on (b)(6) 2020 she had a "severe reaction" to lubricating jelly after an ultrasound procedure.According to the customer report, she had a known allergy to an ingredient in the product at the time of the event.According to the customer she noticed "itching sensation" in the back of her throat within five minutes of leaving the office.She reports developing "painful welts" where the gel was applied.Per the customer report "body began to shake, my heart rate increased and my tongue and throat began to swell.I crushed and ingested several benadryl pills and immediately showered for approx.90 sec to wash the remaining gel from the effected area.Exiting the shower, i became lightheaded and dizzy and struggled to breathe.I called 911 and a vehicle was dispatched to my home.I sat down and tried to relax and steady my breathing, and after several minutes was able to breathe more deeply and began to feel less dizzy.My body began to shake uncontrollably, which continued for several hours.At that time i declined the paramedics offer to visit the emergency room.However, within the following days i experienced delayed reactions with similar symptoms (drop in blood pressure/blood o2 levels (monitored by a nurse at my workplace)/dizziness/shortness ofbreath) and ultimately visited the emergency room for care several days later.I was prescribed prednisone + h2 blockers (pepcid) for five days, and was recommended to take a general allergy pill during that time (allegra).After that, my symptoms finally resolved".There is no additional information available at this time.The sample is not available to be returned for evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

Reaction requiring prescription steroid.

• Brand Name: Medline
• Type of Device: JELLY,LUBE,STERILE,FLIP TOP,TUBE,4-OZ
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16036384
• MDR Text Key: 306063522
• Report Number: 1417592-2022-00243
• Device Sequence Number: 1
• Product Code: KMJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2022

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: Other
• Device Model Number: MDS032290
• Device Catalogue Number: MDS032290
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/20/2022
• Initial Date FDA Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other