MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAB TOUGH STRIPS WATERPROOF; TAPE AND BANDAGE, ADHESIVE

Model Number 381370048336

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

Patient Problems Anaphylactic Shock (1703); Erythema (1840); Itching Sensation (1943); Rash (2033); Skin Inflammation/ Irritation (4545); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient identifier, age at time of event, gender, weight and ethnicity were not provided for reporting.This report is for one (1) bab tough strips waterproof 20s usa 381370048336 8137004833usa 8137004833usa, lot number n/a.Udi # (b)(4).Upc-381370048336.Lot number - ni.Exp- na.Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Consumer reported an event with band aid bandage tough strips waterproof.After accidentally cutting his/her arm on the job, the consumer went home, cleaned out the wound and applied a bandage.After 2 days, the consumer¿s skin became irritated and the consumer developed a very itchy rash that within a week spread across the entire arm, down the left side torso and on thighs.Consumer went to urgent care, where was told that the consumer was on the border of anaphylactic shock.As of three weeks, the consumer¿s skin is still tender and bright pink.Consumer is on antibiotics, two separate antihistamines and needs to carry an epipen around with him/her.

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 and 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.Additional information section: b5: three medwatches (8041154-2021-00023; 8041154-2021-00031; 8041154-2021-00032) are being submitted as three devices were involved with the same event description.See medwatches 8041154-2021-00023 & 8041154-2021-00031 & 8041154-2021-00032.It should be noted, that this submission is potentially the same event/consumer that was submitted under 8041154-2021-00023 & 8041154-2021-00031 & 8041154-2021-00032.The same consumer is potentially represented in each one of those medwatches.Although the events are very similar in nature and they are social media reviews, it cannot be determined conclusively that these are the same consumer.Therefore, these medwatches will be submitted out of an abundance of caution and will be treated as independent submissions and complaints if information is obtained that was not available for the follow-up (01) medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Three medwatches (8041154-2021-00023 & 8041154-2021-00031 & 8041154-2021-00032) are being submitted as three devices were involved with the same event description.See medwatches 8041154-2021-00023 & 8041154-2021-00031 & 8041154-2021-00032.It should be noted, that this submission is potentially the same event/consumer that was submitted under 8041154-2021-00023 & 8041154-2021-00031 & 8041154-2021-00032.The same consumer is potentially represented in each one of those medwatches.Although the events are very similar in nature and they are social media reviews, it cannot be determined conclusively that these are the same consumer.Therefore, these medwatches will be submitted out of an abundance of caution and will be treated as independent submissions and complaints.

• Brand Name: BAB TOUGH STRIPS WATERPROOF
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview rd; skillman NJ 08558 9418
• MDR Report Key: 12373766
• MDR Text Key: 268354112
• Report Number: 8041154-2021-00023
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381370048336
• UDI-Public: (01)381370048336(10)NI
• 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
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 381370048336
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 08/27/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention