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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Swelling (2091); Tissue Damage (2104); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

2320643-2016-00008 is associated with argus case (b)(4), breathe right (unknown).Breathe right (unknown) is marketed as breathe right nasal strips in the us.

Event Description

Serious reaction to adhesive [device allergy]; swollen nose [nasal mucosal swelling]; skin on nose turned red [erythema]; blisters on nose [blister]; welting on nose [welts].Case description: this case was reported by a consumer via call center representative and described the occurrence of device allergy in a female patient who received breathe right nasal strips (breathe right (unknown)) nasal strip for product used for unknown indication.On an unknown date, the patient started breathe right (unknown).On an unknown date, an unknown time after starting breathe right (unknown), the patient experienced device allergy (serious criteria other: serious per reporter), nasal mucosal swelling, erythema, blister and welts.On an unknown date, the outcome of the device allergy, nasal mucosal swelling, erythema, blister and welts were unknown.The reporter considered the device allergy to be related to breathe right (unknown).It was unknown if the reporter considered the nasal mucosal swelling, erythema, blister and welts to be related to breathe right (unknown).Additional details the patient reported that she tried the breathe right strips (variant unknown) and had a serious reaction to the adhesive.Her nose swelled and the skin turned red with welting and blisters as if it were badly burned.No further information provided.

Manufacturer Narrative

Conclusion/root cause: this product is manufactured using medical grade raw materials that have been approved for skin contact.Strip adhesion can vary due to skin type and proper cleaning prior to application.Consumers should follow the instructions for best adhesion properties during use.The consumer should also follow the included instructions that come packaged within each carton of breathe right nasal strips, which references the best way to apply and remove the strips.Without samples or lot information we cannot further investigate this complaint.This complaint is unsubstantiated.

Event Description

Case description: this case was reported by a consumer via call center representative and described the occurrence of device allergy in a female patient who received breathe right nasal strips (breathe right (unknown)) nasal strip for product used for unknown indication.On an unknown date, the patient started breathe right (unknown).On an unknown date, an unknown time after starting breathe right (unknown), the patient experienced device allergy (serious criteria other: serious per reporter), nasal mucosal swelling, erythema, blister and welts.On an unknown date, the outcome of the device allergy, nasal mucosal swelling, erythema, blister and welts were unknown.The reporter considered the device allergy to be related to breathe right (unknown).It was unknown if the reporter considered the nasal mucosal swelling, erythema, blister and welts to be related to breathe right (unknown).Additional details: the patient reported that she tried the breathe right strips (variant unknown) and had a serious reaction to the adhesive.Her nose swelled and the skin turned red with welting and blisters as if it were badly burned.No further information provided.Case correction for the initial information received on 06 aug 2016.The event of device allergy amended to serious adverse reaction.The event device allergy removed from the case (previously was coded in error ).Follow-up information received on 22 august 2016: this case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a female patient who received breathe right nasal strips (breathe right (unknown)) nasal strip for product used for unknown indication.On an unknown date, the patient started breathe right (unknown).On an unknown date, an unknown time after starting breathe right (unknown), the patient experienced adverse reaction (serious criteria other: serious per reporter), nasal mucosal swelling, erythema, blister, welts and product quality issue.On an unknown date, the outcome of the adverse reaction, nasal mucosal swelling, erythema, blister, welts and product quality issue were not reported.The reporter considered the adverse reaction to be related to breathe right (unknown).It was unknown if the reporter considered the nasal mucosal swelling, erythema, blister and welts to be related to breathe right (unknown).Upon investigation the complaint was found to be unsubstantiated.

Event Description

Serious reaction to adhesive [adverse reaction].Swollen nose [nasal mucosal swelling].Skin on nose turned red [erythema].Blisters on nose [blister].Welting on nose [welts].Case description: this case was reported by a consumer via call center representative and described the occurrence of device allergy in a female patient who received breathe right nasal strips (breathe right (unknown)) nasal strip for product used for unknown indication.On an unknown date, the patient started breathe right (unknown).On an unknown date, an unknown time after starting breathe right (unknown), the patient experienced device allergy (serious criteria other: serious per reporter), nasal mucosal swelling, erythema, blister and welts.On an unknown date, the outcome of the device allergy, nasal mucosal swelling, erythema, blister and welts were unknown.The reporter considered the device allergy to be related to breathe right (unknown).It was unknown if the reporter considered the nasal mucosal swelling, erythema, blister and welts to be related to breathe right (unknown).Additional details: the patient reported that she tried the breathe right strips (variant unknown) and had a serious reaction to the adhesive.Her nose swelled and the skin turned red with welting and blisters as if it were badly burned.No further information provided.Case correction for the initial information received on 06 aug 2016.The event of device allergy amended to serious adverse reaction.The event device allergy removed from the case (previously was coded in error ).

• Brand Name: BREATHE RIGHT (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: 5876934
• MDR Text Key: 52169147
• Report Number: 2320643-2016-00008
• 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,Followup,Followup
• Report Date: 08/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2016
• Was Device Evaluated by Manufacturer?: No
• 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