MAUDE Adverse Event Report: NEXT SCIENCE SITEGUARD; WOUND IRRIGATION SOLUTION

Model Number	SL-0008
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	04/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As part of capa 0032, a retrospective review was conducted to analyze the failure to submit this mdr within the required 30-day timeframe.The review identified inadequacies in the complaint handling procedure, including the absence of standardized definitions for reportable events aligned with fda regulations.This lack of harmonization significantly contributed to the misidentification of this complaint as a reportable mdr.Additionally, the complaint handling unit did not have a structured workflow to guide decision-making when initial information was insufficient, further impacting timely and accurate reporting.
Event or Problem Description
The physician applied siteguard to the breast pocket, in the "gutter area," which refers to the lateral edge of the pocket near the underarm.The siteguard solution remained in the pocket for approximately one minute before being suctioned out.It was reported that the patient developed a hematoma following the surgery.

• Brand Name: SITEGUARD
• Common Device Name: WOUND IRRIGATION SOLUTION
• Manufacturer (Section D): NEXT SCIENCE; 10550 deerwood park blvd; ste 300; jacksonville FL 32256
• Manufacturer (Section G): HOLOPACK VERPACKUNGSTECHNIK GMBH; banhofstrasse; sulzbach-laufen, baden-wurttemb 74429 ; GM 74429
• Manufacturer Contact: rizwan qamar ; 10550 deerwood park blvd; ste 300; jacksonville, FL 32256
• MDR Report Key: 21313621
• Report Number: 3012271775-2025-00001
• Device Sequence Number: 12804221
• Product Code: FRO
• UDI-Device Identifier: 00370858000270
• UDI-Public: 00370858000270
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/04/2025

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: Health Professional
• Device Expiration Date: 06/04/2022
• Device Model Number: SL-0008
• Device Lot Number: YH069
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Female