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

Catalog Number UNKNOWN

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 02/22/2021

Event Type  Injury  

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 chelsea and westminster hospital (uk).Primevigilance did reach out to obtain more information 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 Description

It was reported that a patient developed unilateral eczematous eruption with multiple small pustules affecting the site of surgery in reaction to chloraprep with tint.Per article email: abstract an [omitted] with a background of metastatic osteosarcoma was referred to dermatology with an acute, itchy rash that had developed within 24 h of surgical excision of an isolated left lung metastasis.On examination, he had a striking unilateral eczematous eruption with multiple small pustules affecting the side of surgery with subsequent dissemination to the left arm and torso.He was systemically well with normal blood indices.Skin swab for microbiology was negative.Given the unilateral distribution of the eruption involving the side of surgery, an acute allergic contact dermatitis to chlorhexidine in chloraprep with tint or the adhesive used to apply the surgical drapes was suspected.He was treated with topical emollients, topical steroids and oral flucloxacillin to cover for secondary bacterial infection, with complete resolution within 1 week.The patient was patch tested to chloraprep with tint, chlorhexidine, isopropyl myristrate, plastics and glues, surgical drape adhesive, acrylics and nursing allergens, including iodine and other hospital chemicals.There was a positive result to chloraprep with tint, indicating allergy to the constituent sunset yellow, given negative reactions to chlorhexidine and isopropyl myristate.The diagnosis was pustular allergic contact dermatitis (acd) to sunset yellow.Pustular acd is rare, with reactions to the topical antibacterial nitrofurazone, isoconazole nitrate, topical minoxidil 2%, fluorouracil black rubber 1%, tricholoroethylene, disperse dyes and fragrances having been reported.The clinical appearance of pustular acd has been described as multiple small pustules, 0.5-1 mm in size, on a background of erythema and swelling.It is associated with marked pruritus.Chlorhexidine is known to cause irritant contact dermatitis, acd and anaphylaxis.Despite its widespread use as an antiseptic agent, such reactions are rare.Patch testing to both chlorhexidine and chloraprep with tint in this case helped to identify the culprit as the azo dye sunset yellow.Acd to sunset yellow has rarely been reported.Mccleskey described acd to sunset yellow in orange antiseptic solution confirmed by patch testing (mccleskey pe.Dermatitis to fd&c yellow no.6 dye in orange antiseptic solution.Arch dermatol 2011; 147: 1124-5).Guin found four positive reactions to the dye amongst 144 patchtested patients guin jd.Patch testing to fd&c and d&c dyes.Contact dermatitis 2003; 49 217 18.This case highlights the importance of considering testing to the specific ingredients of a product when acd is suspected and represents a rare presentation of pustular acd to sunset yellow dye.

• Brand Name: CHLORAPREP UNKNOWN
• Type of Device: 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 11435966
• MDR Text Key: 247073605
• Report Number: 3004932373-2021-00105
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/24/2021

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: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2021
• Initial Date FDA Received: 03/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18 YR