MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NORTHFIELD MEDLINE LUBRICATING JELLY; LUBRICANT, PATIENT

Model Number MDS032290

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

Patient Problems Adult Respiratory Distress Syndrome (1696); Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Itching Sensation (1943); Pain (1994); Tachycardia (2095); Dizziness (2194); Sore Throat (2396); Low Oxygen Saturation (2477); Shaking/Tremors (2515); Angioedema (4536)

Event Date 02/11/2020

Event Type  Injury  

Event Description

I had a severe allergic reaction to polyethylene glycol in medline lubricating jelly following a transvaginal/abdominal ultrasound.Product info: https://www.Medline.Com/media/catalog/docs/msds/msd_sds0049.Pdf product contains 6-7% poly(oxy-1,2-ethanediyl),.Alpha.-hydro-.Omega.-hydroxy- , otherwise known by its epa registry name: polyethylene glycol i previously had a severe allergic reaction to polyethylene glycol (peg) in (b)(6) 2019, ingested via miralax, so had a known allergy at the time of this reaction.In (b)(6) 2020 i visited a radiology office for a routine ultrasound to check placement of an iud (intrauterine device).The procedure was quick and i left the office within five minutes of the gel being applied both abdominally/transvaginal.While walking to my vehicle i noticed an itching sensation at the back of my throat, similar to what i experienced during my first peg reaction.During my five minute drive home, i developed painful welts on my abdomen and inner thighs where the gel had been applied, and the itching sensation spread across my tongue and down my throat.Upon arriving home, my 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 of breath) 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.

• Brand Name: MEDLINE LUBRICATING JELLY
• Type of Device: LUBRICANT, PATIENT
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NORTHFIELD
• MDR Report Key: 15987597
• MDR Text Key: 305721656
• Report Number: MW5113808
• Device Sequence Number: 1
• Product Code: KMJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/12/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: MDS032290
• Device Catalogue Number: MDS032290
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2022
• Patient Sequence Number: 1
• Treatment: IUD (INTRAUTERINE DEVICE), BENADRYL, PREDNISONE, PEPCID, ALLEGRA.
• Patient Outcome(s): Other; Life Threatening
• Patient Age: 25 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White