MAUDE Adverse Event Report: MEDLINE INDUSTRIES; EYE PACK

Catalog Number	DYNJ55096B
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that per the physician, the patient was removed from the surgical area after the unknown eye procedure was complete and it was noticed post-surgery that there was a small white fiber in the patient's lens.The eye had to be flushed to try and remove the lint, but the lint was unable to be flushed out.The patient was brought back into surgery to remove the lint from the lens.The surgeon reported that the product was inspected before use and no major fibers were noticed at that time.Per the surgeon, there was no permanent damage to the patient.The actual sample involved in the incident was not returned for evaluation.A number of attempts were made to obtain additional information, however the customer did not provide any additional information.There was no report of any additional adverse patient consequence and no effect on the patient's stability as a result of the incident.A sample has not been returned for evaluation however, due to the reported incident and subsequent need for surgical intervention, 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 fiber got on a patients lens from the towel.

• Common Device Name: EYE PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES; three lakes drive; northfield IL 60093
• MDR Report Key: 7079747
• Report Number: 1423395-2017-00028
• Device Sequence Number: 11045530
• Product Code: OJK
• UDI-Device Identifier: 10889942678303
• UDI-Public: 10889942678303
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/04/2017

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?: Yes
• Operator of Device: Physician
• Device Catalogue Number: DYNJ55096B
• Device Lot Number: 17UB0822
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2017
• Initial Report FDA Received Date: 12/04/2017
• 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: Required Intervention