MAUDE Adverse Event Report: RICHARD WOLF MEDICAL CURVED NASAL SCISSORS

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/07/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, i was admitted to (b)(6) for outpatient csf repair exploratory surgery.An hour or so into surgery, the surgeon went to make a skin path from nasal lining on the right side of my nose.It was at this time the tips of the scissors broke off and fell.After x-raying my stomach, chest / lungs, the surgeon found them lodged behind the adenoid.The retrieval was quite difficult and resulted in a partial adenoidectomy, a week long hospitalization, including three days in icu, as well as current health suffrage.

• Brand Name: CURVED NASAL SCISSORS
• Type of Device: NASAL SCISSORS
• Manufacturer (Section D): RICHARD WOLF MEDICAL
• MDR Report Key: 7214853
• MDR Text Key: 98235127
• Report Number: MW5074753
• Device Sequence Number: 1
• Product Code: KBD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 22 YR
• Patient Weight: 79