MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC.; BOOZMAN HOF PACK 2

Model Number	VAL042EYBHA
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that two separate patients were undergoing cataract surgery and at the end of the procedure fibers from the blue or towel were noted in the patient's eye (this report addresses patient #2).The doctor was able to remove the fibers with irrigation and forceps with no additional intervention required.There was no impact on the patient's stability or outcome related to the reported issue.The procedure was completed without further incident or delay.The customer is reportedly doing fine with no troubles noted no follow up treatment was required.The sample was not returned to the manufacturer for evaluation.No root cause could be determined.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that a patient was undergoing cataract surgery and at the end of the procedure fibers from the blue or towel were noted in the patient's eye requiring removal of the fiber by the doctor.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: BOOZMAN HOF PACK 2
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 10401424
• Report Number: 1423395-2020-00023
• Device Sequence Number: 19568995
• Product Code: LRO
• UDI-Device Identifier: 10193489236583
• UDI-Public: 10193489236583
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/10/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: VAL042EYBHA
• Device Catalogue Number: VAL042EYBHA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 08/13/2020
• 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: Required Intervention