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

Model Number 381370056850

Device Problems Labelling, Instructions for Use or Training Problem (1318); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 05/15/2020

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient identifier, weight, and ethnicity and race were not provided for reporting.Upc #: 381370056850, lot #: 200218, udi #: (b)(4).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 february 18, 2020.Visual inspection was performed on the retain samples and the returned samples and all results met specification.Product was returned for investigation.Lot number and upc were verified.The product met specifications.This is two of two medwatches being submitted as two devices were involved in this event.See medwatch 1000599868-2020-00004.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 female consumer reported an event with flexible fabric extra large band aid bandages.On (b)(6) 2020, the consumer used the bandages for a cut.When the cut got infected, the consumer sought medical attention through urgent care and was prescribed antibiotics.The consumer is still experiencing some redness from the skin.This is two of two medwatches being submitted as two devices were involved in this event.See medwatch 1000599868-2020-00004.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 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.Correction, additional information, device evaluation: product was returned for investigation.Lot number and upc were verified.The product did not met specifications for labelling since the two returned band-aid boxes state made in brazil and band-aids inside state made in china.Visual inspection was performed on the retain samples and the returned samples and carton was noted as ¿made in brazil¿ and strips was noted as ¿made in china¿.The retain samples did not met the specifications for product labelling.Field sample photos were evaluated by j&j shanghai and based on investigation performed it was concluded that, there was a typographical error on the carton and that it was not suspect mixed product.The country on the carton was updated for future lots, starting with 200423.There is no impact to the product quality, patient safety or process as a result of this finding.This is two of two follow-up medwatches being submitted as two devices were involved in this event.See medwatch 1000599868-2020-00004.The same patient is represented in each medwatch.If information is obtained that was not available for the follow-up medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

During investigation, it was noted that the 2 boxes of band-aid flexible fabric - extra large lot 200218 carton states made in brazil, whereas, the band-aids inside the carton state made in china.

• Brand Name: BAB FLEXIBLE FABRIC EXTRA LARGE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview rd; skillman NJ 08558 9418
• MDR Report Key: 10205949
• MDR Text Key: 197344245
• Report Number: 1000599868-2020-00005
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381370056850
• UDI-Public: (01)381370056850(10)200218
• 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: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 381370056850
• Device Lot Number: 200218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Event Location: Other
• Date Manufacturer Received: 06/25/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR