MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-12-06 for BREATHE RIGHT NASAL STRIPS manufactured by Webtec Div Of Scarpa Healthcare.
[129532325]
2320643-2018-00006 is associated with argus case (b)(4), breathe right nasal strips.
Patient Sequence No: 1, Text Type: N, H10
[129532326]
Piece of hard plastics from the strip penetrating right eye [(ye penetration). Right eye sustained an abrasion to the cornea (corneal abrasion). Case description: this case was reported by a lawyer and described the occurrence of eye penetration in a male patient who received breathe right nasal strips nasal strip for product used for unknown indication. Concomitant products included no therapy. On an unknown date, the patient started breathe right nasal strips. On an unknown date, an unknown time after starting breathe right nasal strips, the patient experienced eye penetration (serious criteria gsk medically significant) and corneal abrasion. The action taken with breathe right nasal strips was unknown. On an unknown date, the outcome of the eye penetration and corneal abrasion were unknown. It was unknown if the reporter considered the eye penetration and corneal abrasion to be related to breathe right nasal strips. Additional information: on and about (b)(6) 2018, the patient was using the breath right strip product properly and according to the instruction. Applying the strip on his nose are the patient was awoken by piece of hard plastics from the strip penetrating right eye. The patient right eye sustained an abrasion to the cornea which required surgery and not properly healed requiring extensive treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320643-2018-00006 |
| MDR Report Key | 8139611 |
| Report Source | CONSUMER |
| Date Received | 2018-12-06 |
| Date of Report | 2018-12-04 |
| Date Mfgr Received | 2019-02-13 |
| Date Added to Maude | 2018-12-06 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BREATHE RIGHT NASAL STRIPS |
| Generic Name | NASAL STRIPS |
| Product Code | LWF |
| Date Received | 2018-12-06 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | DA |
| 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 | 2018-12-06 |