MAUDE Adverse Event Report: FREUDENBERG MEDICAL, LLC BLOM-SINGER NASAL SEPTAL PERFORATION PROSTHESIS; NASAL SEPTAL PROSTHESIS

Device Problems Device Unsafe to Use in Environment (2918); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/06/2019

Event Type  Injury  

Event Description

During a review of the maude database on 11/22/2019, a report was discovered alleging an adverse event involving an inhealth nasal septal prosthesis.Freudenberg medical had not been made aware of this event prior to the maude review.The report reads as follows: "a (b)(6) y/o female was admitted on (b)(6) 2019 due to osteomyelitis of her right big toe secondary to an infected ulcer.Podiatrist documented on (b)(6) 2019 he believed an mri was necessary for developing plan of care for this pt.Mri order was placed by hospitalist at 12:41 pm on (b)(6) 2019.Pt's mri was performed on (b)(6) 2019 at 20:00.On (b)(6) 2019, hospitalist documented "ent consultation requested, mri may have dislodged septal button (through out of field)".Ent consult occurred on (b)(6) 2019, ent provider noted pt complained that nasal button was dislodged during the mri on (b)(6) 2019.Per the medical record, pt denied aspiration, choking, or epistaxis.Ent provider documented nasal button was removed without difficulty from left nares and recommended f/u in the outpatient setting.Notification of possible event regarding mri occurred on (b)(6) 2019.After further investigation, it was determined the pt had a nasal septal perforation prosthesis placed on (b)(6) 2019.On (b)(6) 2019 the vendor confirmed the device placed "should not be in situ during mri examination." freudenberg medical does not have any contact information to facilitate a follow-up with the reporter.

• Brand Name: BLOM-SINGER NASAL SEPTAL PERFORATION PROSTHESIS
• Type of Device: NASAL SEPTAL PROSTHESIS
• Manufacturer (Section D): FREUDENBERG MEDICAL, LLC; 1110 mark ave; carpinteria 93013
• Manufacturer Contact: matthew arbogast ; 1110 mark ave; carpinteria 93013 ; 8055765471
• MDR Report Key: 9501086
• MDR Text Key: 188803557
• Report Number: 2025182-2019-00004
• Device Sequence Number: 1
• Product Code: LFB
• Combination Product (y/n): N
• PMA/PMN Number: K131745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/22/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention