MAUDE Adverse Event Report: CAREFUSION 213, LLC 0113 UNKNOWN CHLORAPREP; 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 Fungal Infection (2419)

Event Date 02/21/2022

Event Type  Injury  

Event Description

Material#: unknown.Batch#: unknown.It was reported of an other event.Verbatim: reported issues: purpose: to highlight the relevance of the study of microbiological corneal samples in the treatment and typing of atypical corneal ulcers.Epicoccum nigrum is a fungus belonging to the yeast category.It is found in cereal and fruit crops.It is used in the medical and agricultural industry as an antimicrobial.Methods: we present a descriptive study (case report).We have performed a clinical, imaging and microbiological follow up of a patient with an atypical corneal ulcer in the right eye.A corneal scraping was performed for microbiological analysis, resulting in the presence of a filamentous fungus.The sample was sent to a specialized laboratory in (b)(6) confirming the presence of epicoccum nigrum in the corneal tissue.Results: the patient presented with decreased visual acuity and pain in the right eye unrelated to trauma, nor is she a contact lens wearer.The patient lives in a rural area and works as a fruit picker.Examination showed an infiltrated corneal ulcer with significant epithelial defect and stromal edema.The best corrected visual acuity was 0.05.A sample was taken for culture and treatment with voriconazole and chlorhexidine was started.The culture confirms the existence of filamentous fungus, and treatment with topical natamycin was started.The culture was analyzed in a laboratory outside our center and was positive for epicoccum nigrum.After 10 months with no activity observed, penetrating keratoplasty was performed on the right eye and the patient currently has a better corrected visual acuity of 0.3.Conclusions: this is the first clinical case in which the presence of epicoccum nigrum is detected in corneal tissue.There are no previous cases documented in scientific literature.Due to the difficulty in confirming its presence in cultures in non-specialized centers, we could suppose that perhaps its prevalence in corneal ulcers was higher than what is known.

Manufacturer Narrative

(b)(6).Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).

• Brand Name: UNKNOWN CHLORAPREP
• Type of Device: 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL
• Manufacturer (Section D): CAREFUSION 213, LLC 0113; 1550 northwestern dr; el paso TX 79912
• 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: 13702469
• MDR Text Key: 291615708
• Report Number: 3004932373-2022-00069
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other