FDA Adverse Event Injury Summary report: N

UNKNOWN_INSTRUMENTS_PRODUCT

MDR report key: 19820215 · Received July 24, 2024

Report

Report Number
3006345872-2024-00011
Event Type
Injury
Date Received
July 24, 2024
Date of Event
February 5, 2021
Report Date
July 24, 2024
Manufacturer
STRYKER INSTRUMENTS-KALAMAZOO
Product Code
PNZ
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
MI, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 0

IT WAS REPORTED THROUGH A CLINICAL LITERATURE REVIEW THAT A HEALTHY 51-YEAR-OLD FEMALE WITH A HISTORY OF EUSTACHIAN TUBE DYSFUNCTION PRESENTED ONE DAY POSTOPERATIVE FOLLOWING A BALLOON SINUPLASTY AND BILATERAL ETD WITH SUDDEN ONSET NECK SWELLING, DYSPHAGIA, AND PAIN AFTER AN EPISODE OF SNEEZING. THE PROCEDURE WAS UNCOMPLICATED TECHNICALLY, PER PRIMARY SURGEON¿S REPORT, AND IMMEDIATELY POSTOPERATIVELY THE PATIENT ENDORSED MILD BILATERAL EPISTAXIS BUT NO DISCOMFORT. UPON PHYSICAL EXAMINATION POST OP DAY 1, THE PATIENT PRESENTED WITH ERYTHEMATOUS NECK, FACIAL SWELLING, TRISMUS, AND CREPITUS. FLEXIBLE FIBEROPTIC LARYNGOSCOPY SHOWED MILD BLOODY SECRETIONS BUT NO FRANK MUCOSAL INJURY. A CT SCAN OF THE NECK AND CHEST SHOWED EXTENSIVE SOFT TISSUE EMPHYSEMA CENTERED AT THE LEFT TORUS TUBARIUS, EXTENDING INTO THE IPSILATERAL RETROPHARYNGEAL AND CAROTID SPACES AND INTO THE MEDIASTINUM. THE PATIENT WAS MANAGED CONSERVATIVELY WITH ANTIBIOTIC PROPHYLAXIS AND OBSERVATION BY THE OTOLARYNGOLOGY AND CARDIOTHORACIC SURGERY TEAMS. DAILY CHEST X-RAYS DEMONSTRATED CONTINUED IMPROVEMENT OF THE PNEUMOMEDIASTINUM AND SUBCUTANEOUS EMPHYSEMA. THE PATIENT¿S SYMPTOMS AMELIORATED, AND THE PATIENT WAS DISCHARGED HOME AFTER 3 DAYS ON ORAL ANTIBIOTICS WITH NO FURTHER COMPLICATIONS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
364950 UNKNOWN_INSTRUMENTS_PRODUCT EUSTACHIAN TUBE BALLOON DILATION DEVICE PNZ STRYKER INSTRUMENTS-KALAMAZOO

Patients

Seq Age Sex Outcome Treatment
1 51 YR Female Hospitalization