MAUDE Adverse Event Report: WEBTEC DIV OF SCARPA HEALTHCARE BREATHE RIGHT NASAL STRIPS EXTRA CLEAR

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

I have a serious adverse allergic reaction to latex rubber.[allergic reaction].Case description: this case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a male patient who received breathe right nasal strips (breathe right nasal strips extra clear) nasal strip (batch number unk, expiry date unknown) for product used for unknown indication.On an unknown date, the patient started breathe right nasal strips extra clear at an unknown dose and frequency.On an unknown date, an unknown time after starting breathe right nasal strips extra clear, the patient experienced allergic reaction (serious criteria other: serious per reporter).The action taken with breathe right nasal strips extra clear was unknown.On an unknown date, the outcome of the allergic reaction was unknown.It was unknown if the reporter considered the allergic reaction to be related to breathe right nasal strips extra clear.Additional details: the patient had reported that purchase and try the extra clear nasal strips.He read the enclosed instructions within the package.And he had a serious adverse allergic reaction to latex rubber.He did not read the back-caution warnings with regards to the product containing natural latex rubber.Truthfully, he assumed the product would be safe, as on the front it does state it was "drug free".Latex rubber obviously was not a drug.But since the strips do contain latex rubber somewhere, he do believe that should have been noted on the front packaging, not in the rear fine print.

• Brand Name: BREATHE RIGHT NASAL STRIPS EXTRA CLEAR
• Type of Device: NASAL STRIPS
• Manufacturer (Section D): WEBTEC DIV OF SCARPA HEALTHCARE; knoxville TN
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 10372523
• MDR Text Key: 202701122
• Report Number: 2320643-2020-00004
• Device Sequence Number: 1
• Product Code: LWF
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 07/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other