MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; DBD-PHACO PACK

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/12/2024

Event Type  Injury  

Manufacturer Narrative

It was reported by the customer contact that a "fiber in the eye" was found.It was reported that the fiber was from the or towel.No additional information is available at this time.A sample was requested to be returned for evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

"fiber in the eye".

• Type of Device: DBD-PHACO PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18652099
• MDR Text Key: 334680119
• Report Number: 1423395-2024-00006
• Device Sequence Number: 1
• Product Code: OJK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/06/2024

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 02/06/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other