MAUDE Adverse Event Report: ANGELINI PHARMA INC. ALCAVIS 50; HIGH LEVEL DISINFECTANT FOR CONNECTIONS

Catalog Number	15501
Health Effect - Clinical Codes	Skin Irritation (2076); Injury (2348); Superficial (First Degree) Burn (2685)
Date of Event	01/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned.
Event or Problem Description
Angelini pharma inc.Was received a complaint filled with (b)(4) about an adverse event involving alcavis 50.On march 1st, (b)(4) was contacted by the patient about an incident that happened on (b)(6) 2017.The patient stated that while using alcavis 50 to clean the catheter while preparing for his peritoneal dialysis, he spilled alcavis 50 on his underpants.He did not notice that his underwear was wet and went to bed with the wet garments.In the next morning, he felt that the genital area was uncomfortable and noticed his underpants was discolored.He then realized that he had spilled alcavis 50 on himself and went to bed without exchange it.He noticed that the genitals were reddish and sensitive; he then showered and washed the affected area with antimicrobial soap, treated with hydrogen peroxide, and with triple antibiotic ointment.Two/three days later, he had a visit with his nephrologist who referred him to the primary doctor, and this to his urologist.With the urologist, he began treatment with lidocaine gel (4%) and clotrimazole and betamethasone dipropionate cream.Region is still having an open would and is still painful.Patient is diabetic and undergoes hyperbaric treatment.Patient continues using alcavis 50.

• Brand Name: ALCAVIS 50
• Common Device Name: HIGH LEVEL DISINFECTANT FOR CONNECTIONS
• Manufacturer (Section D): ANGELINI PHARMA INC.; 8322 helgeman cr; gaithersburg MD 20877 4103
• MDR Report Key: 6966376
• Report Number: 3001239013-2017-00001
• Device Sequence Number: 16474983
• Product Code: FKO
• UDI-Device Identifier: 00898021000051
• UDI-Public: 00898021000051
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K885037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 03/31/2017

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: Patient Family Member or Friend
• Device Catalogue Number: 15501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2017
• Initial Report FDA Received Date: 10/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR