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

Model Number 381370044314

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

Patient Problems Pain (1994); Impaired Healing (2378); Skin Tears (2516); Skin Infection (4544); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient age at time of event, weight and ethnicity were not provided for reporting.Upc - 381370044314.Lot number - ni.Udi: (b)(4).Lot number: ni.Exp: na.This report is for one (1) band aid brand adhesive bandages flexible fabric all one size 30ct usa 381370044314 8137004431usa, 8137004431usa, 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.This is 1 of 3 med-watches being submitted for band aid brand adhesive bandages flexible fabric all one size 30ct usa 381370044314 as three devices were involved in this event.See medwatch 2214133-2021-00034 for j&j band aid brand first aid cushion care gauze pads 4x4 10ct usa 381371161270 and medwatch 2214133-2021-00035 j&j band aid brand first aid tru absorb gauze sponges 4 x 4 50ct usa 381371161478.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

A consumer reported an event with band aid brand adhesive bandage flexible fabric all one size, j&j band aid brand first aid cushion care gauze pads 4x4 and j&j band aid brand first aid tru absorb gauze sponges 4 x 4.Consumer reported she scratched her leg putting on slacks.With home remedies, it healed but had a small scab on it, so the consumer put a flexible fabric band aid on it.When she removed it, she noticed the skin was irritated where the tape had been.The pharmacist at (b)(6) recommended cushion care gauze pads or tru-absorb gauze sponges.Each of these stuck to her skin and she ended up with a huge sore caused by the pads.She went to her primary care doctor who recommended she be treated at the wound care center at (b)(6) which resulted in three visits before her leg was healed.This is 1 of 3 med-watches being submitted for band aid brand adhesive bandages flexible fabric all one size 30ct usa 381370044314 as three devices were involved in this event.See medwatch 2214133-2021-00034 for j&j band aid brand first aid cushion care gauze pads 4x4 10ct usa 381371161270 and medwatch 2214133-2021-00035 j&j band aid brand first aid tru absorb gauze sponges 4 x 4 50ct usa 381371161478.The same patient is represented in each medwatch.

Event Description

I scratched my leg putting on slacks.With home remedies it healed but had a small scab on it so i put a band aid on it.When i removed it, i noticed the skin was irritated where the tape had been.

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: d4: lot number ¿ 2650b.Corrected section: d4: udi: (b)(4); upc: 381370044314; lot number: 2650b; exp- na.H4, h6: 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.This is 1 of 3 follow-up (01) med-watches being submitted for band aid brand adhesive bandages flexible fabric all one size 30ct usa 381370044314 as three devices were involved in this event.See medwatch 2214133-2021-00034 for j&j band aid brand first aid cushion care gauze pads 4x4 10ct usa 381371161270 and medwatch 2214133-2021-00035 j&j band aid brand first aid tru absorb gauze sponges 4 x 4 50ct usa 381371161478.The same patient is represented in each medwatch.If information is obtained that was not available for the follow-up (01) medwatch, a 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 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.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 september 21, 2020.This is 1 of 3 follow-up (02) med-watches being submitted for band aid brand adhesive bandages flexible fabric all one size 30ct usa 381370044314 as three devices were involved in this event.See medwatch 2214133-2021-00034 for j&j band aid brand first aid cushion care gauze pads 4x4 10ct usa 381371161270 and medwatch 2214133-2021-00035 j&j band aid brand first aid tru absorb gauze sponges 4 x 4 50ct usa 381371161478.The same patient is represented in each medwatch.If information is obtained that was not available for the follow-up (02) medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This is 1 of 3 follow-up (02) med-watches being submitted for band aid brand adhesive bandages flexible fabric all one size 30ct usa 381370044314 as three devices were involved in this event.See medwatch 2214133-2021-00034 for j&j band aid brand first aid cushion care gauze pads 4x4 10ct usa 381371161270 and medwatch 2214133-2021-00035 j&j band aid brand first aid tru absorb gauze sponges 4 x 4 50ct usa 381371161478.The same patient is represented in each medwatch.

Event Description

Consumer medical claim letter dated on (b)(6) 2022 was received and reviewed.It was reported that on (b)(6) 2021 the patient¿s associated diagnosis was an open wound of right lower leg, subsequent encounter, edema of lower extremity and fluid retention.The wound location is left lower leg wound.The wound dressing change 3x per week, with ag alginate.The patient¿s leg was healed after three visits to clinic.It was also reported the patient received apixaban 5mg.

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 data: b5 - updated reporter verbatim.This is 1 of 3 follow-up (04) med-watches being submitted for band aid brand adhesive bandages flexible fabric all one size 30ct usa 381370044314 as three devices were involved in this event.See medwatch 2214133-2021-00034 for j&j band aid brand first aid cushion care gauze pads 4x4 10ct usa 381371161270 and medwatch 2214133-2021-00035 j&j band aid brand first aid tru absorb gauze sponges 4 x 4 50ct usa 381371161478.The same patient is represented in each medwatch.If information is obtained that was not available for the follow-up (04) medwatch, a 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 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 data: b5 - updated reporter verbatim.This is 1 of 3 follow-up (03) med-watches being submitted for band aid brand adhesive bandages flexible fabric all one size 30ct usa 381370044314 as three devices were involved in this event.See medwatch 2214133-2021-00034 for j&j band aid brand first aid cushion care gauze pads 4x4 10ct usa 381371161270 and medwatch 2214133-2021-00035 j&j band aid brand first aid tru absorb gauze sponges 4 x 4 50ct usa 381371161478.The same patient is represented in each medwatch.If information is obtained that was not available for the follow-up (03) medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Consumer medical claim letter dated on (b)(6), 2022 was received.Based on review of the letter, the consumer stated the following new and additional information ¿tearing the skin on my leg causing an infection ¿and medication was identified as ¿walgreen antibiotic prescription - cephalexin 500mg capsules¿.This is 1 of 3 follow-up (03) med-watches being submitted for band aid brand adhesive bandages flexible fabric all one size 30ct usa 381370044314 as three devices were involved in this event.See medwatch 2214133-2021-00034 for j&j band aid brand first aid cushion care gauze pads 4x4 10ct usa 381371161270 and medwatch 2214133-2021-00035 j&j band aid brand first aid tru absorb gauze sponges 4 x 4 50ct usa 381371161478.The same patient is represented in each medwatch.

• Brand Name: BAB FLEXIBLE FABRIC BANDAGES
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview rd; skillman NJ 08558 9418
• Manufacturer (Section G): BRAZIL CONSUMER; rodovia presidente dutra km 15; são josé dos campos ; BR
• Manufacturer Contact: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 12373188
• MDR Text Key: 268452476
• Report Number: 8041154-2021-00022
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381370044314
• UDI-Public: (01)381370044314(10)NI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/15/2022

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: 381370044314
• Device Lot Number: 2650B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 08/02/2021
• Initial Date FDA Received: 08/26/2021
• Supplement Dates Manufacturer Received: 08/27/2021; 09/13/2021; 02/15/2022; 03/15/2022
• Supplement Dates FDA Received: 09/07/2021; 09/15/2021; 03/04/2022; 03/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2020
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White