MAUDE Adverse Event Report: WEBTEC DIV OF SCARPA HEALTHCARE BREATHE RIGHT (UNK); NASAL STRIPS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Other  

Manufacturer Narrative

Additional information: the adverse event was received via gsk (b)(4), who received the below message from the nephew of the patient.Urgent need of nasal strips.The patient wrote with great urgency.He was from (b)(6) and his grandmother had breathing sickness.She was depended on nasal strips not to have a crisis in the middle of the night.The nasal strips had been removed from the (b)(6) market and they had no other substitute.The patient wanted to ask, if there was any way that the patient can order 50 packages online and transfer the money to the bank account.Action taken with breathe right (unk) was unk.

Event Description

Addiction.Case description: this case was reported by a consumer via other and described the occurrence of addition in a female patient who received breathe right nasal strips (breathe right (unk)) nasal strip for breathing difficult.On an unknown date, the patient started breathe right (unk).On an unknown date, an unknown time after starting breathe right (unk), the patient experienced addiction (serious criteria gsk medically significant).On an unknown date, the outcome of the addiction was unknown.It was unknown if the reporter considered the addiction to be related to breathe right (unk).

• Brand Name: BREATHE RIGHT (UNK)
• Type of Device: NASAL STRIPS
• Manufacturer (Section D): WEBTEC DIV OF SCARPA HEALTHCARE; knoxville TN
• Manufacturer (Section G): GSK
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 5009800
• MDR Text Key: 23943005
• Report Number: 2320643-2015-00007
• 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,foreign,other
• Report Date: 08/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Date Manufacturer Received: 08/04/2015
• 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