MAUDE Adverse Event Report: WEBTEC A DIVISION OF SCARPA HEALTHCARE BREATHE RIGHT EXTRA (UNKNOWN); NASAL STRIPS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bruise/Contusion (1754)

Event Type  Injury  

Manufacturer Narrative

Report # 2320643-2016-00007 is associated with (b)(4), breathe right extra (unknown).Breathe right extra (unknown) is marketed as breathe right nasal strips in the u.S.

Event Description

Application site bruise [application site bruise].Case description: this case was reported by a consumer via call center representative and described the occurrence of application site bruise in a male patient who received breathe right nasal strips (breathe right extra (unknown)) nasal strip for an unknown indication.On (b)(6) 2016, the patient started breathe right extra (unknown).On an unknown date, less than a day after starting breathe right extra (unknown), the patient experienced application site bruise (serious criteria gsk medically significant).On an unknown date, the outcome of the application site bruise was unknown.It was not reported if the reporter considered the application site bruise to be related to breathe right extra (unknown).[clinical course]: on (b)(6) 2016, the patient developed bruise-like spot in the application site about one hour after he put breathe right extra (unknown).

• Brand Name: BREATHE RIGHT EXTRA (UNKNOWN)
• Type of Device: NASAL STRIPS
• Manufacturer (Section D): WEBTEC A DIVISION OF SCARPA HEALTHCARE; 5900 middle view way; knoxville TN 37909
• Manufacturer (Section G): GSK
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 5813518
• MDR Text Key: 50174986
• Report Number: 2320643-2016-00007
• Device Sequence Number: 1
• Product Code: LWF
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 07/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Date Manufacturer Received: 07/14/2016
• 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