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

Lot Number UNKNOWN

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

Patient Problems Headache (1880); Hypersensitivity/Allergic reaction (1907); Pain (1994); Rash (2033); Swelling (2091); Burning Sensation (2146)

Event Type  Injury  

Manufacturer Narrative

The report # 2320643-2018-00007 is associated with (b)(4), breathe right nasal strips.

Event Description

I got a serious reaction to it i never had in my life [adverse reaction]; i got a serious reaction to it i never had in my life [emergency care examination].Woke up with a rash on my nose [rash].I had pain all over, all over my head [headache].I had pain all over [pain].My head was swollen [swelling].Its still red on my cheeks and head.[red face].It was burning [burning sensation].Case description: this case was reported by a consumer and described the occurrence of adverse reaction in a (b)(6) year-old female patient who received breathe right nasal strips (breathe right nasal strips extra) nasal strip (batch number 1252125, expiry date unknown) for difficulty breathing.Co-suspect products included breathe right nasal strips nasal strip (batch number unknown, expiry date unknown) for difficulty breathing.On (b)(6) 2018, the patient started breathe right nasal strips extra.On an unknown date, the patient started breathe right nasal strips.On (b)(6) 2018, 1 days after starting breathe right nasal strips extra and an unknown time after starting breathe right nasal strips, the patient experienced rash, headache, pain, swelling, red face and burning sensation.On an unknown date, the patient experienced adverse reaction (serious criteria other: serious as per reporter) and emergency care examination.Breathe right nasal strips extra was discontinued on (b)(6) 2018 (dechallenge was positive).The action taken with breathe right nasal strips was unknown.On an unknown date, the outcome of the adverse reaction and emergency care examination were unknown and the outcome of the rash, headache, swelling, red face and burning sensation were recovering/resolving and the outcome of the pain was recovered/resolved.The reporter considered the adverse reaction to be related to breathe right nasal strips extra and breathe right nasal strips.It was unknown if the reporter considered the emergency care examination, rash, headache, pain, swelling, red face and burning sensation to be related to breathe right nasal strips extra and breathe right nasal strips.Additional information: adverse event information was received via call on 7 december 2018.The consumer reported that "i have used breathe right nasal strips in the past but not the extra strength.Is there any other ingredients that was put in here? i got a serious reaction to it i never had in my life.I had to go to the emergency room.I used the regular ones without the material and i used these with the material.I'm thinking it's the extra.I used one on (b)(6) and woke up with a rash on my nose; on the top of my nose.The next day i did not recognize myself.I looked like a monster.I had to go back to another emergency room; it was getting worse.I did not put another one on.I had pain all over, all over my head.The tan ones pop off your nose.In the middle of the night and i threw them out.My head was swollen, it was terrible.It's going back to normal now but not fully.It's still red on my cheeks and head.I went to the dermatologist and he gave me something to put on it.It was burning." the primary packaging lot number is unknown and the secondary packaging lot number is 1252125.

• Brand Name: BREATHE RIGHT NASAL STRIPS
• 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: 8170012
• MDR Text Key: 130619929
• Report Number: 2320643-2018-00007
• Device Sequence Number: 1
• Product Code: LWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 12/07/2018
• 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
• Patient Age: 66 YR