MAUDE Adverse Event Report: ANGELINI PHARMA INC. EXSEPT PLUS; NON-STERILE WOUND IRRIGATION SOLUTION, ANTIMICROBIAL

Model Number	500ML
Health Effect - Clinical Code	Skin Discoloration (2074)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
User contacted manufacturer to discuss about a possible complaint involving exsept plus.Patient stated to be new to peritoneal dialysis and that she is been using the product for about 3 months.At a visit to the doctor for another reason, her son noticed darkening of the skin around the region in which she applies the product.Patient stated that she does not use any other product in the area and is careful in not getting the region wet.Patient does not have any other symptom.Region is not sensitive to the touch or painful.
Event or Problem Description
(b)(6) is new on peritoneal dialysis.(b)(6) started using the product on (b)(6) 2017.Since initiation, (b)(6) observed darkening of the skin of the region in which the product is used.(b)(6) does not believe to be allergic to sodium hypochlorite.

• Brand Name: EXSEPT PLUS
• Common Device Name: NON-STERILE WOUND IRRIGATION SOLUTION, ANTIMICROBIAL
• Manufacturer (Section D): ANGELINI PHARMA INC.; 8322 helgerman ct; gaithersburg MD 20877 4103
• MDR Report Key: 6966379
• Report Number: 3001239013-2017-00008
• Device Sequence Number: 16514846
• Product Code: FQH
• UDI-Device Identifier: 00898021000075
• UDI-Public: 00898021000075
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K082858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 09/27/2017

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: Lay User/Patient
• Device Expiration Date: 03/01/2019
• Device Model Number: 500ML
• Device Catalogue Number: 15117
• Device Lot Number: 0284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2017
• 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: 55 YR