MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-12-17 for BREATHE RIGHT NASAL STRIPS EXTRA manufactured by Webtec Div Of Scarpa Healthcare.
[130548021]
Mfr report is associated with argus case (b)(4), breathe right nasal strips extra.
Patient Sequence No: 1, Text Type: N, H10
[130548022]
I got a serious reaction to it i never had in my life [adverse reaction], [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) 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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320643-2018-00008 |
| MDR Report Key | 8170018 |
| Report Source | CONSUMER |
| Date Received | 2018-12-17 |
| Date of Report | 2018-12-07 |
| Date Mfgr Received | 2018-12-07 |
| Date Added to Maude | 2018-12-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | PO BOX 13398 |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 8888255249 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BREATHE RIGHT NASAL STRIPS EXTRA |
| Generic Name | NASAL STRIPS |
| Product Code | LWF |
| Date Received | 2018-12-17 |
| Lot Number | 1252125 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WEBTEC DIV OF SCARPA HEALTHCARE |
| Manufacturer Address | KNOXVILLE TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-17 |