MAUDE Adverse Event Report: EQUATE / PERRIGO COMPANY EQUATE NASAL STRIPS; DILATOR NASAL

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

Patient Problems Pain (1994); Tissue Damage (2104)

Event Date 05/20/2018

Event Type  No Answer Provided  

Event Description

Used equate nasal strip on (b)(6) 2018, upon removal on (b)(6) 2018 just when i got to the end on the left, it felt like a sting.Looked in the mirror and my skin had come off on the left.Bought at (b)(6).Frequency: once at bedtime, on the skin.Dates of use: (b)(6) 2018 - (b)(6) 2018.To stop snoring, keep nasal passage open.The problem stopped after the person reduced the dose or stopped taking or using the product, after two weeks.

• Brand Name: EQUATE NASAL STRIPS
• Type of Device: DILATOR NASAL
• Manufacturer (Section D): EQUATE / PERRIGO COMPANY
• MDR Report Key: 7645320
• MDR Text Key: 112843561
• Report Number: MW5078106
• Device Sequence Number: 1
• Product Code: LWF
• 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: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Age: 73 YR
• Patient Weight: 59