MAUDE Adverse Event Report: WEBTEC A DIVISION OF SCARPA HEALTHCARE BREATHE RIGHT NASAL STRIPS ADVANCED

Lot Number 31040244E12

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bacterial Infection (1735); Purulent Discharge (1812); Erythema (1840); Rash (2033); Local Reaction (2035); Skin Irritation (2076); Swelling (2091); Burning Sensation (2146)

Event Type  Injury  

Event Description

This case was reported by a consumer and described the occurrence of application site infection in a female pt who received breathe right nasal strips for snoring.A physician or other health care professional has not verified this report.On an unk date, the pt started breathe right nasal strips (topical).At an unk time after starting breathe right nasal strips, the pt experienced application site infection, staphylococcal infection, application site reaction, application site swelling, application site burning, application site redness, application site papules, application site inflammation and raw at application site.The pt stated that she got a staph infection from the nasal strip.She stated that she as a burning sensation on her nose, and her nose is red, swollen, inflamed and 'broken out with bumps'.She stated that one side of her nose is irritated and raw.She stated that her nose is "dripping pus with an infection".She reported that she is required to go back to the doctor again today ((b)(6) 2014) to determine if further treatment will be required.This case was assessed as medically serious by gsk.The pt was treated with antibiotics and unk (unspecified medication).Treatment with breathe right nasal strips was discontinued.At the time of reporting, the events were unresolved.Sae report revision was made on 28 april 2014.

Manufacturer Narrative

The mfr's report number for this case is 2320643-2014-00002.Breathe right nasal strips are manufactured in (b)(4) and neither the product nor lot number for this product are available.(b)(4).

Event Description

(b)(4).

Manufacturer Narrative

Patient was treated with antibiotics and unknown (unspecified medication).Treatment with breathe right nasal strips was discontinued.At the time of reporting, the events were unresolved.Sae report revision was made on 28 april 2014.This case narrative was inadvertently excluded from the for original sae report, and has now been added.The manufacturer's report number for this case is 2320643-2014-00002.Breathe right nasal strips are manufactured in (b)(4) and neither the product nor lot number for this product are available.(b)(4).

Manufacturer Narrative

2320643-2014-00002 is associated with argus case (b)(4), breathe right nasal strips advanced.

Event Description

Application site infection.Staphylococcal infection.Application site reaction.Application site swelling.Application site burning.Application site redness.Application site papules.Application site inflammation.Raw at application site [application site irritation].Case description: this case was reported by a consumer and described the occurrence of application site infection in a female patient who received breathe right nasal strips for snoring.A physician or other health care professional has not verified this report.On an unknown date, the patient started breathe right nasal strips (topical).At an unknown time after starting breathe right nasal strips, the patient experienced application site infection, staphylococcal infection, application site reaction, application site swelling, application site burning, application site redness, application site papules, application site inflammation and raw at application site.The patient stated that she got a staph infection from the nasal strip.She stated that she has a burning sensation on her nose, and her nose is red, swollen, inflamed and "broken out with bumps".She stated that one side of her nose is irritated and raw.She stated that her nose is "dripping pus with an infection".She reported that she is required to go back to the doctor again today ((b)(6) 2014) to determine if further treatment will be required.This case was assessed as medically serious by gsk.The patient was treated with antibiotics and unknown (unspecified medication).Treatment with breathe right nasal strips was discontinued.At the time of reporting, the events were unresolved.Sae report revision was made on 28 april 2014.This case narrative was inadvertently excluded from the original sae report, and has now been added.The manufacturer's report number for this case is 2320643-2014-00002.Breathe right nasal strips are manufactured in (b)(4) and neither the product nor lot number for this product are available.Follow up information was received on 18 april 2017 via returned consumer authorization form.The consumer reported healthcare professionals address.Also the suspect product was updated to breathe right nasal strips advanced.Lot code was 31040244e12.Consumers demographic details were updated.Case comment: consumer reported she is required to go back to the doctor again today to determine if further treatment will be required.

• Brand Name: BREATHE RIGHT NASAL STRIPS ADVANCED
• 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; 5900 middle view way; knoxville TN 37909
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 3669614
• MDR Text Key: 4344513
• Report Number: 2320643-2014-00002
• Device Sequence Number: 1
• Product Code: LWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 31040244E12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2017
• 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
• Treatment: UNSPECIFIED MEDICATIONS
• Patient Outcome(s): Other
• Patient Sex: Female