MAUDE Adverse Event Report: ANGELINI PHARMA INC. EXSEPT PLUS - 100ML; ANTIMICROBIAL SKIN & WOUND CLEANSER

Catalog Number	15104
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Dyspnea (1816); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023 (b)(6) was notified by the fda via email, that report # mw5148319 had been received through the fda's medwatch program.The report was submitted by fresenius medical care, a distributor of angelini pharma inc.Infection prevention products.The report stated that a female patient experienced swelling of the neck, and severe breathing difficulties while using exsept plus antiseptic.No additional information was provided.
Additional Manufacturer Narrative
The root cause cannot be identified.There is limited device specific information provided, no batch number is available, and no sample for evaluation.Without a batch reference, a manufacturing and technical evaluation cannot be completed.No product quality related trend was identified for the exsept plus product.Product labeling indicates not to use the device in case of a known or suspected hypersensitivity to sodium hypochlorite.Additionally, the label warns not to inject, ingest, or inhale the product.

• Brand Name: EXSEPT PLUS - 100ML
• Common Device Name: ANTIMICROBIAL SKIN & WOUND CLEANSER
• Manufacturer (Section D): ANGELINI PHARMA INC.; 230 peachtree st.; suite 1250; atlanta GA 30303
• Manufacturer (Section G): ANGELINI PHARMA SPA; via pontasso 13; casella, ge 16015 ; IT 16015
• Manufacturer Contact: randall hester ; 230 peachtree st; suite 1250; atlanta, GA 30303 ; 8007262308
• MDR Report Key: 18384328
• Report Number: 3001239013-2023-00001
• Device Sequence Number: 2772724
• Product Code: FQH
• UDI-Device Identifier: 00898021000105
• UDI-Public: 00898021000105
• Combination Product (Y/N): N
• PMA/510(K) Number: KO82858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2023

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: Lay User/Patient
• Device Catalogue Number: 15104
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female