MAUDE Adverse Event Report: CAREFUSION, INC CHLORAPREP UNKNOWN; 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL

Catalog Number	UNKNOWN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Reaction (2414)
Date of Event	08/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).No additional information was provided by (b)(6) hospital.Propharma did reach out to obtain with no success.Should additional information be available in the future, the complaint will be re-opened and investigated.All complaints are reviewed during monthly quality/safety meetings.In addition, complaints are trended at monthly quality data analyst meetings and quarterly plant management review meetings.
Event or Problem Description
Material no.: unknown batch no.: unknown.It was reported that the patient experienced a severe allergic reaction using chloraprep product.Am writing this letter to inform you of a severe, life threatening reaction i had to your chloroprep (chlorhexidine gluconate) product.On tuesday (b)(6) 2020,1 had breast cancer surgery at (b)(6) hospital in (b)(6).Chloroprep was used as a presurgical prep for my surgery for excision of a cancerous tumor and lymph node.The day after surgery i felt good but noticed that a red irritated area had developed next to the clear adhesive plastic covering the surgical incisions.Over the next two days, the red irritation turned in to red inflammation with large painful blisters both underand around the plastic and under the gauze under the plastic bandage.By saturday, the blisters were oozing to the point i had to change my shirt several times a day.I called my surgeon and was told to take benadryl tablets and cover the blisters with benadryl cream, which did nothing but allow the extreme pain to get worse.By this time, dealing with cancer and the excruciating pain were too much to bear.I next saw my surgeon on tuesday, (b)(6).She was shocked at the severity of the reaction and prescribed a cortisone cream, which i tried, and again no relief, the pain was still excruciating and unbearable.The next day my surgeon was not available so that afternoon out of fear and desperation, i contacted both my dermatologist and my primary care doctor and explained my situation.Both doctors understood the urgency and immediately made appointments to see me early the next day.At my appointment, my primary care doctor was shocked to see the severity of my reaction and gave me an injection of prednisone and prescriptions for prednisone tablets, and 10 days of doxycycline, an antibiotic.I later met with my dermatologist who concurred with my primary care doctor, she was also shocked at the severity of the reaction and upped the dose of prednisone.This treatment eventually started to provide relief.Because of the inflammation and possibility of infection in the open wound on my chest, my oncologist would not start my chemotherapy treatment until after the wound healed.After my wound healed, i went for the surgical placement of an infusion port for chemotherapy.As a precaution, my husband wrote "severe allergy do not use chloroprep" on my chest with a sharpie pen.The prep nurse said it was good thing we did; the doctor had my chart with him with the directive against using chloroprep, but he wasn't yet in the surgical suite to share this information.The prep nurse was under anesthesia and couldn't tell her myself.Without this precaution, i could have had another serious reaction involving extreme pain, infection or death.My experience with chloroprep was the worst experience of my life.It was like my skin was on fire.I was in extreme pain that only got worse.When my husband tried to gently spread cream on the affected area, i screamed and cried.I literally thought i was going to die.I reluctantly took oxycodone to help with the pain which provided some relief.I now know there are cautions about these reactions on the label of chloroprep solution, but during my briefing about the surgery, these reactions were never mentioned.I told the doctors that i had allergies including a severe allergy to shellfish.Writing that there is an allergy to chloroprep on medical records apparently is not sufficient.I also understand that chloroprep is so widely used that it may not be listed on the label of some products where it is an ingredient.This may be a problem for me in the future.Personally, i will get a medical alert bracelet with a caution and make sure all my medical records indicate that i have this life-threatening allergy.I think cardinal health needs to eliminate or at least mitigate future occurrences.Why not do a skin, blood or some other allergy testing prior to using the product? also, medical professionals who may encounter these allergic reactions need to be educated and provided a protocol for identification, assessment and treatment.My reaction was different, i experienced a life-threatening reaction that required my immediate action involving several doctors to save my life.Due to excruciating pain, mental distress, fear of dying, and the fact that my life saving chemotherapy treatment was delayed because of your product, i am asking cardinal health to fairly compensate me.I just can't adequately explain the suffering i experienced, but i have enclosed several pictures of my allergic reaction to help you understand.

• Brand Name: CHLORAPREP UNKNOWN
• Common Device Name: 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL
• Manufacturer (Section D): CAREFUSION, INC; 5175 south royal atlanta dr; tucker GA 30084
• MDR Report Key: 10882333
• Report Number: 3004932373-2020-00130
• Device Sequence Number: 2812074
• Product Code: LRJ
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/23/2020

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
• Operator of Device: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 11/22/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other