MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC J&J BAND AID BRAND FIRST AID PAPER TAPE; TAPE AND BANDAGE, ADHESIVE

Model Number 381370048817

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

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient age, weight and ethnicity were not provided for reporting.This report is for (j&j band aid first aid paper tape 2.5cmx9m (1x10) can 381370048817 8137004881cab).Device is not distributed in the united states but is similar to device marketed in the usa (j&j band aid brand first aid paper tape 1x10yds 1ct usa 381371161539 8137116153usa).Upc = (b)(4).Lot number = (10)ni.Expiration date = n/a.Udi: (b)(4).Device is not expected to be returned for manufacturer review/investigation.Device is not distributed in the united states but is similar to device marketed in the usa (j&j band aid brand first aid paper tape 1x10yds 1ct usa 381371161539 8137116153usa).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 this initial medwatch, an additional follow-up medwatch will be filed as appropriate.

Event Description

This incident involved a female consumer using j&j band aid® first aid paper tape (lot not provided) for the first time.The consumer reported that the previous weekend she used a j&j band aid® first aid paper tape to cover a picc line in her arm.When she wanted to remove the tape, the tape was ¿practically stuck like glue¿.While removing it, the tape removed a piece of her skin leaving an open sore, which got infected.After the first use, the consumer discontinued using j&j band aid® first aid paper tape.She consulted a doctor who prescribed an unspecified product.The symptoms improved after consumer stopped using the product and while reporting this event consumer had no symptoms present.

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.D4: udi: (b)(4).D10: device returned for evaluation.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 january 10, 2020.H3,h6: product was returned for investigation.A field sample verification of the medical ae cannot be done via a visual evaluation.Device history records review was completed.H6 - health impact 4315.If information is obtained that was not available for this follow up medwatch, an additional follow-up medwatch will be filed as appropriate.

• Brand Name: J&J BAND AID BRAND FIRST AID PAPER TAPE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview rd; skillman NJ 08558 9418
• MDR Report Key: 10467671
• MDR Text Key: 205008765
• Report Number: 2214133-2020-00032
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381370048817
• UDI-Public: (01)381370048817(10)NI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 09/02/2020

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: 381370048817
• Device Lot Number: 0100CA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Event Location: Other
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 08/28/2020
• Supplement Dates Manufacturer Received: 09/02/2020
• Supplement Dates FDA Received: 09/29/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention