MAUDE Adverse Event Report: SWABS, CANNULA'S; APPLICATOR, ABSORBENT TIPPED, NON-STERILE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Reaction (2414)

Event Type  Injury  

Event Description

I went to emergency room for what i thought was a stomach virus.While in the emergency room they started an iv drip.Within mins of starting the iv drip, i broke out in a cold sweat, puffy hives all over my body, bright red rash covering my entire body, heart was racing.They thought i was having a reaction to either pepcid or zofran.They started administering an iv drip of benadryl.A few hours later i left hosp but had rash all over my body; 3 days later i was back in hosp with vomiting and diarrhea again.Once again, they started an iv drip because i was dehydrated, and again within mins i broke out in a cold sweat, chills, red rash all over body, puffy hives, etc.Once again they thought i was reading to anti-nausea medicine.They administered benadryl again through an iv drip.They sent me home with prednisone and told me to continue taking benadryl.Fast forward a year and half later and i wound up in emergency room because i woke up feeling out of sorts.They decided in the emergency room to start an iv drip of sodium chloride.They said in case i was dehydrated this couldn't hurt.Well, it almost killed me.Once again the min they swabbed my arm, inserted the catheter and turned on the iv all of the above symptoms started again.They administered benadryl by iv drip and waiting until my heart and blood pressure returned to normal before releasing me.After these 3 episodes i knew i needed to find out what was going on since all the hosps had no answer.Quite scary when you are in hosp having allergic reaction and they do not know why.Anyway, i saw an allergist and it was determined that i am severely allergic to chlorhexidine.It was confirmed it was on the swab they used on my arm before inserting the catheter and the cannula was coated with agb (another term for chlorhexidine).This was a very frightening experience for me and i live in horror of being exposed to it on a daily basis.There needs to be more awareness to chlorhexidine.I have mentioned it to drs and nurses and they are not even aware of what it is.How could this be? if you need any further info my email address is (b)(6).Thank you, (b)(6).

• Brand Name: SWABS, CANNULA'S
• Type of Device: APPLICATOR, ABSORBENT TIPPED, NON-STERILE
• MDR Report Key: 9174800
• MDR Text Key: 162307060
• Report Number: MW5090337
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/09/2019
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 53