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

Device Problems Unexpected Therapeutic Results (1631); Improper or Incorrect Procedure or Method (2017)

Patient Problems Purulent Discharge (1812); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Ulcer (2274); Weight Changes (2607)

Event Type  No Answer Provided  

Event Description

Pus at application site [application site infection]; sores at application site [application site ulcer]; bleeding at application site [application site hemorrhage]; liver disease [hepatic disease]; malnourished; weight loss; health deteriorate [general physical health deterioration]; drug maladministration.This case was reported by a consumer and described the occurrence of application site infection in a (b)(6) female pt who received breathe right nasal strips (breathe right nasal strips extra) nasal strip for an unk indication.Concurrent medical conditions included myelitis transverse (a spinal cord disease, diagnosed about 7 years ago.) in 2010, the pt started breathe right nasal strips extra.In 2014, several years after starting breathe right nasal strips extra, the pt experienced weight loss and drug maladministration.On an unk date, the pt experienced application site infection (serious criteria gsk medially significant), application site ulcer (serious criteria gsk medically significant), application site hemorrhage, hepatic disease, malnutrition and general physical health deterioration.The breathe right nasal strips extra were withdrawn (dechallenge was negative).On an unk date, the outcome of the application site infection, application site ulcer, application site hemorrhage, hepatic disease, malnutrition, weight loss and general physical health deterioration were not recovered/not resolved and the outcome of the drug maladministration was unk.It was unk if the reporter considered the application site infection, application site ulcer, application site hemorrhage, hepatic disease, malnutrition, weight loss and general physical health deterioration to be related to breathe right nasal strips extra.Additional details: the pt's mother reported the adverse events of sores and pus at application site, application site hemorrhage, malnourished, weight loss, liver disease, and drug maladministration from using the breathe right extra tan.The reporter stated that her daughter has been using the product nightly for the past four years (approx 2010) and during that time her daughter's health had begun to deteriorate.The pt's mother reported that she was not blaming our product but was exploring different possibilities that could have caused her daughter's events.The mother reported drug maladministration, over the past two and a half months (approx 2014), when her daughter began using the breathe right strips 24/7 even over sores, pus, and bleeding that was occurring at the application site.During the two and a half month time period (approx 2014), while she started using the product 24/7, the mother reported that her daughter's health continued on a decline and she lost 10 pounds which left her weighing 67 pounds at the time of this report.The mother reported that her daughter was also diagnosed with liver disease and told by her doctor that she was malnourished.

• Brand Name: BREATHE RIGHT NASAL STRIPS EXTRA
• Type of Device: NASAL STRIPS
• Manufacturer (Section D): WEBTEC DIV OF SCARPA HEALTHCARE; knoxville TN
• Manufacturer (Section G): GSK
• Manufacturer Contact: p.o. box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 4360356
• MDR Text Key: 5118815
• Report Number: 2320643-2014-00013
• Device Sequence Number: 1
• Product Code: LWF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Type of Report: Initial
• Report Date: 12/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Date Manufacturer Received: 12/09/2014
• 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: 29 YR