MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-06-23 for BREATHE RIGHT NASAL STRIPS EXTRA manufactured by Webtec A Division Of Scarpa Healthcare.
[78290737]
Number 2320643-2017-00006 is associated with argus case (b)(4), breathe right nasal strips extra.
Patient Sequence No: 1, Text Type: N, H10
[78290738]
Skin cancer of the nose/ doctor seemed to think something looked like skin cancer to her [skin cancer]. Case description: this case was reported by a consumer and described the occurrence of skin cancer in a (b)(6) female patient who received breathe right nasal strips (breathe right nasal strips extra) nasal strip (batch number 49695bxcm16, expiry date unknown) for difficulty breathing. This case was associated with a product complaint. The patient's past medical history included epistaxis. Previously administered products included vicks vapor rub with an associated reaction of no adverse event. Concomitant products included no therapy. On an unknown date, the patient started breathe right nasal strips extra. On an unknown date, an unknown time after starting breathe right nasal strips extra, the patient experienced skin cancer (serious criteria gsk medically significant) and product complaint. Breathe right nasal strips extra was continued with no change. On an unknown date, the outcome of the skin cancer was not recovered/not resolved and the outcome of the product complaint was unknown. It was unknown if the reporter considered the skin cancer and product complaint to be related to breathe right nasal strips extra. This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details, the consumer reported she went to a dermatologist at the end of (b)(6) 2017 and she said that she had skin cancer on her nose. The consumer told the doctor she used the product every night. The doctor asked how were the strips and she told the doctor fine. Then the doctor said she was going to burn all of the skin off of her nose or freeze it. The doctor said nothing more after that. The consumer said she was going to another dermatologist at the end of (b)(6) 2017 to get a second opinion. The consumer said she had cancer before. The consumer said she did not think the product was leaving anything on her nose but the doctor seemed to think something looked like skin cancer to her. She had not heard the finally word on this yet. The consumer reported in the winter when the inside of her nose gets dried and bloody, she used her little finger to wipe the inside of her nose with vicks vapor rub on both nostrils. It was not thick, just a thin coating. It lubricated the inside of her nose and it did not get dry and cracked and sometimes bloody in the winter. She had done this for years, long before using breathe right strips. She said it worked well with using the strips. The consumer reported that she had a defective box. The papers that have to peel off of the strip to put them on the nose, she used about half of this box and the paper did not have the little slit in the middle that folds over, making it very hard to get them off. She said one box had the slits, the other did not have slits in about 10 of the strips.
Patient Sequence No: 1, Text Type: D, B5
[109421188]
Mdr 2320643-2017-00006 is associated with (b)(4), breathe right nasal strips extra.
Patient Sequence No: 1, Text Type: N, H10
[109421189]
Case description: this case was reported by a consumer and described the occurrence of skin cancer in a (b)(6) female patient who received breathe right nasal strips (breathe right nasal strips extra) nasal strip (batch number 49695bxcm16, expiry date unknown) for difficulty breathing. This case was associated with a product complaint. The patient's past medical history included epistaxis. Previously administered products included vicks vapor rub with an associated reaction of no adverse event. Concomitant products included no therapy. On an unknown date, the patient started breathe right nasal strips extra. On an unknown date, an unknown time after starting breathe right nasal strips extra, the patient experienced skin cancer (serious criteria gsk medically significant) and product complaint. Breathe right nasal strips extra was continued with no change. On an unknown date, the outcome of the skin cancer was not recovered/not resolved and the outcome of the product complaint was unknown. It was unknown if the reporter considered the skin cancer and product complaint to be related to breathe right nasal strips extra. This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details, the consumer reported she went to a dermatologist at the end of (b)(6) 2017 and she said that she had skin cancer on her nose. The consumer told the doctor she used the product every night. The doctor asked how were the strips and she told the doctor fine. Then the doctor said she was going to burn all of the skin off of her nose or freeze it. The doctor said nothing more after that. The consumer said she was going to another dermatologist at the end of (b)(6) 2017 to get a second opinion. The consumer said she had cancer before. The consumer said she did not think the product was leaving anything on her nose but the doctor seemed to think something looked like skin cancer to her. She had not heard the finally word on this yet. The consumer reported in the winter when the inside of her nose gets dried and bloody, she used her little finger to wipe the inside of her nose with vicks vapor rub on both nostrils. It was not thick, just a thin coating. It lubricated the inside of her nose and it did not get dry and cracked and sometimes bloody in the winter. She had done this for years, long before using breathe right strips. She said it worked well with using the strips. The consumer reported that she had a defective box. The papers that have to peel off of the strip to put them on the nose, she used about half of this box and the paper did not have the little slit in the middle that folds over, making it very hard to get them off. She said one box had the slits, the other did not have slits in about 10 of the strips. Follow up information was received on 10 july 2017 from patient. The patient returned authorization form without the contact details of physician. The patient stated that "i am not going to send you my old or new dermatologist names. I did not like the old one anyway and after she told me i had skin cancer on my nose and after i said i used breathe rite strips, she did nothing. After few weeks of thinking, i called a partner on the other side of town. I saw him this morning and he said i do not have cancer on my nose or face. He said i should use sunscreen and take care and come back in a year, so that is as far as i will go. I am still going to use breathe rite strips and i already sent you samples of the ones without a cut in the paper backing".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320643-2017-00006 |
| MDR Report Key | 6663190 |
| Report Source | CONSUMER |
| Date Received | 2017-06-23 |
| Date of Report | 2017-06-14 |
| Date Mfgr Received | 2017-08-04 |
| Date Added to Maude | 2017-06-23 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 |
| Manufacturer G1 | GSK |
| 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 | 2017-06-23 |
| Lot Number | 49695BXCM16 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WEBTEC A DIVISION OF SCARPA HEALTHCARE |
| Manufacturer Address | 5900 MIDDLE VIEW WAY KNOXVILLE TN 37909 US 37909 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 1 | 1. Other | 2017-06-23 |