MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2019-05-20 for BREATH RIGHT ORIGINAL manufactured by Webtec Div Of Scarpa Healthcare.
[145489405]
Argus case id (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[145489406]
Swelling/slightly swollen all over her body/feeling swollen [swelling], cellulite in face [cellulite], inflammation in face/swollen face [facial swelling], swollen in legs, arms [peripheral swelling], swollen lips [lip swelling], swollen nose [nasal inflammation]. Case description: this case was reported by a consumer via call center representative and described the occurrence of swelling in a (b)(6) female patient who received breathe right nasal strips (breath right original) nasal strip (batch number 1801935, expiry date unknown) for product used for unknown indication. Concurrent medical conditions included blood cholesterol increased. Concomitant products included rosuvastatin calcium (crestor). On (b)(6) 2019, the patient started breath right original. On (b)(6) 2019, 4 days after starting breath right original, the patient experienced swelling (serious criteria hospitalization). On (b)(6) 2019, the patient experienced swollen lips and nasal inflammation. On (b)(6) 2019, the patient experienced peripheral swelling. On (b)(6) 2019, the patient experienced cellulite and swelling of face. Breath right original was discontinued on (b)(6) 2019 (dechallenge was positive). On an unknown date, the outcome of the swelling, cellulite, swelling of face, peripheral swelling, swollen lips and nasal inflammation were recovering/resolving. The reporter considered the swelling, cellulite and swelling of face to be related to breath right original. It was unknown if the reporter considered the peripheral swelling, swollen lips and nasal inflammation to be related to breath right original. Additional details: the initial and follow up was processed together. The consumer reported that she started using breathright. She used it every night. She started feeling swollen and on (b)(6) 2019 she woke up and was slightly swollen all over her body and became more swollen in nose and lips and was swollen in legs, arms, lips and face. On (b)(6) 2019 she visited an ear nose throat physician who gave her a cream for the nose and anti histamine drug (not specified), but the swelling was not resolved, so on she visited the hospital. Follow up information was received from consumer on 03 may 2019: the consumer reported that she was hospitalized and she was diagnosed with cellulite and inflammation in face. The symptoms started recovering. She was on therapy with crestor for many years. She did not started any new drug and did not eat any different food the days she used breathright.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320643-2019-00004 |
| MDR Report Key | 8623394 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2019-05-20 |
| Date of Report | 2019-05-01 |
| Date of Event | 2019-04-28 |
| Date Mfgr Received | 2019-09-20 |
| Date Added to Maude | 2019-05-20 |
| 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 RESEARCH TRIANGLE PARK |
| Manufacturer City | 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 | BREATH RIGHT ORIGINAL |
| Generic Name | NASAL STRIPS |
| Product Code | LWF |
| Date Received | 2019-05-20 |
| Lot Number | 1801935 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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. Hospitalization | 2019-05-20 |