MAUDE Adverse Event Report: INTEGRA LIFE SCIENCE CORPORATION BOWMAN LACRIMAL PROBE DOUBLE-ENDED, STAINLESS STELL 5-1/8"; PROBE, LACHRYMAL

Catalog Number 360-271

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/23/2021

Event Type  Injury  

Event Description

Lacrimal probe broke during use leaving a small linear mental fragment that had to be removed in 2nd surgery.Fda safety report id# (b)(4).

• Brand Name: BOWMAN LACRIMAL PROBE DOUBLE-ENDED, STAINLESS STELL 5-1/8"
• Type of Device: PROBE, LACHRYMAL
• Manufacturer (Section D): INTEGRA LIFE SCIENCE CORPORATION; princeton NJ 08540
• MDR Report Key: 11744582
• MDR Text Key: 248239586
• Report Number: MW5101071
• Device Sequence Number: 1
• Product Code: HNL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 360-271
• Device Lot Number: AZ1905
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/28/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR