MAUDE Adverse Event Report: STRYKER / ENTELLUS MEDICAL, INC LATERA; POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE

Model Number LATAN 120

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Scar Tissue (2060)

Event Date 11/08/2021

Event Type  Injury  

Event Description

Scar formed on my nose and extended out making my nose look like it had a blister on it.Fda safety report id # (b)(4).

• Brand Name: LATERA
• Type of Device: POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE
• Manufacturer (Section D): STRYKER / ENTELLUS MEDICAL, INC
• MDR Report Key: 12916837
• MDR Text Key: 281690512
• Report Number: MW5105723
• Device Sequence Number: 1
• Product Code: NHB
• 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: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: LATAN 120
• Device Lot Number: 221801
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: PRILOSEC; SYMBICORT 160
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White