MAUDE Adverse Event Report: CONSUMER JOHNSON & JOHNSONS INC BAB SHEER BANDAGES; TAPE AND BANDAGE, ADHESIVE

Model Number 381370046691

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

Patient Problems Erythema (1840); Itching Sensation (1943); Scar Tissue (2060); Skin Discoloration (2074); Skin Burning Sensation (4540); Skin Inflammation/ Irritation (4545)

Event Date 04/20/2021

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient weight and ethnicity were not provided for reporting.Udi: (b)(4), upc = (01)381370046691, expiration date= na, lot number =ni.This report is for one (1) bab sheer assorted 80s (b)(4), lot number ni.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.The consumer has reported a band aid was used and may have contributed to the event, the following products are possible devices that were used from this kit: bab sheer assorted 80s, (b)(4).Bab clear water block plus 30s, (b)(4).This is 1 of 2 med-watches being submitted as two possible devices were involved in this event.See medwatch 8041154-2021-00013.The same patient 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

An event was reported with a band aid from band-aid all-purpose first aid kit portable compact 140 pcs.It was reported that the consumer's right hand got injured because of the bandage.The consumer had experienced, scarring, itching, and discoloration after use of the product.The consumer provided follow-up information and stated she went to the hospital and was prescribed antibiotics for her medical event.The consumer stated she only used 1 pad.The consumer has reported a band aid was used and may have contributed to the event, the following products are possible devices that were used from this kit: bab sheer assorted 80s, (b)(4).Bab clear water block plus 30s, (b)(4).This is 1 of 2 med-watches being submitted as two possible devices were involved in this event.See medwatch 8041154-2021-00013.The same patient 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.The consumer has reported a band aid was used and may have contributed to the event, the following products are possible devices that were used from this kit: bab sheer assorted 80s, 8137004669usa.Bab clear water block plus 30s, 8137005659usa.This is 1 of 2 follow-up med-watches being submitted as two possible devices were involved in this event.See medwatch 8041154-2021-00013.The same patient is represented in each medwatch.If information is obtained that was not available for the follow-up #1 medwatch, an additional follow-up medwatch will be filed as appropriate.

Event Description

Based on additional information received from consumer, it was also reported that consumer experienced irritation, burning and redness while using this product.The irritation, burning and redness went away after she stopped using the product however, she's still waiting for the irritation to go away completely and there's still discoloration on her arm.The consumer was using the product twice daily.The consumer has reported a band aid was used and may have contributed to the event, the following products are possible devices that were used from this kit: bab sheer assorted 80s, 8137004669usa.Bab clear water block plus 30s, 8137005659usa.This is 1 of 2 follow-up med-watches being submitted as two possible devices were involved in this event.See medwatch 8041154-2021-00013.The same patient is represented in each medwatch.

• Brand Name: BAB SHEER BANDAGES
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): CONSUMER JOHNSON & JOHNSONS INC; 199 grandview rd; skillman NJ 08558 9418
• MDR Report Key: 12001134
• MDR Text Key: 267479838
• Report Number: 8041154-2021-00012
• 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
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 381370046691
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 06/11/2021
• Initial Date FDA Received: 06/15/2021
• Supplement Dates Manufacturer Received: 07/20/2021
• Supplement Dates FDA Received: 07/29/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR