MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAB PERFECT BLEND CLEAR LIGHT ASST 45S USA 381370057017 8137005701USD; ADHESIVE BANDAGES

Model Number 381370057017

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

Patient Problems Ischemia (1942); Itching Sensation (1943); No Code Available (3191)

Event Date 09/13/2018

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient age at time of event, ethnicity and race were not provided for reporting.Udi #: (b)(4).Upc = (b)(4).Expiration date = na.Lot number = 1048b.Device is not expected to be returned for manufacturer review/investigation.Concomitant medical products and therapy dates: drug: simvastatin; 10mg 1x daily; high cholesterol; consumer still on drug.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.A review of the device history records has been requested.(b)(4).This is one of two medwatches being submitted as two devices were involved in this event. see medwatch 8041154-2018-00025.The same consumer is represented in each medwatch.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A female consumer of unknown age reported that she used 2 band aid clear strips on her face, one on the bridge of her nose and one on her lip.The consumer applied the product on (b)(6) 2018 for the first time and within 2 hours her face was itching, red and warm not only where she applied the band-aids but all over her face.The consumer stated she removed the band aids on (b)(6) 2018 and did not reuse them.The consumer stated that she did have to go to her doctor.The doctor prescribed hydrocortisone cream as a treatment.The consumer since applying the cream her face is getting better but is still red.This is one of two medwatches being submitted as two devices were involved in this event. the same consumer is represented in each medwatch.

Manufacturer Narrative

Johnson &; johnson consumer, inc.Is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which johnson &; johnson consumer, inc.Has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, johnson & johnson consumer, inc.Or its employees that the report constitutes an admission that the device, johnson &; johnson consumer, inc., or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.H4, h6: device history records review was completed.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition and product was manufactured per specification.The product was manufactured on april 14, 2018.If information is obtained that was not available for the follow-up #1 bab 1 medwatch, an additional follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Johnson & johnson consumer, inc.Is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which johnson & johnson consumer, inc.Has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, johnson & johnson consumer, inc.Or its employees that the report constitutes an admission that the device, johnson & johnson consumer, inc., or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.Patient code 3191 refers to consumer reporting about little blisters.This is one of two medwatches being submitted as two devices were involved in this event.See medwatch 8041154-2018-00025.The same consumer is represented in each medwatch.If information is obtained that was not available for the follow-up 02 bab 1 medwatch, an additional follow-up medwatch will be filed as appropriate.

Event Description

Additional information was received on october 31, 2018 where consumer was reported that her face turned red.Consumer had bumps and spots on her face for two to three weeks and has been dealing with this for six weeks.Additionally, the band-aid was not itchy, but it was uncomfortable with little blisters spread across her face.

• Brand Name: BAB PERFECT BLEND CLEAR LIGHT ASST 45S USA 381370057017 8137005701USD
• Type of Device: ADHESIVE BANDAGES
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview rd; skillman NJ 08558 9418
• MDR Report Key: 7956684
• MDR Text Key: 123428900
• Report Number: 8041154-2018-00024
• Device Sequence Number: 1
• Product Code: KGX
• 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,Followup,Followup
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 381370057017
• Device Lot Number: 1048B
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 10/31/2018
• Patient Sequence Number: 1
• Treatment: SIMVASTATIN 10MG.; SIMVASTATIN 10MG
• Patient Outcome(s): Required Intervention
• Patient Weight: 73