MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC. BAND-AID CLEAR STRIPS 10 AP; TAPE AND BANDAGE, ADHESIVE

Model Number 4901730075558

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

Patient Problems Pain (1994); Skin Inflammation (2443); No Code Available (3191)

Event Date 02/01/2020

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Weight, ethnicity and race were not provided for reporting.This report is for (range - adhesive bandages ap not applicable 0000rgebabapd 0000rgebabapd).Device is not distributed in the united states but is same similar device marketed in the usa (band-aid unspecified usa, clear 10s).Udi: (b)(4), upc = ni, expiration date= na, lot number = 180305c.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 (band-aid unspecified usa, clear 10s).The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.(b)(4).This is 2 of 2 med-watches being submitted as two devices were involved in this event.See medwatch 2214133-2020-00012.The same patient is represented in each medwatch.If information is obtained that was not available for this medwatch, an additional follow-up medwatch will be filed as appropriate.

Event Description

Consumer (father) applied band-aid to his (b)(6) year old daughter to cover a bug bit.The consumer stated the area where the pad was became inflamed and was painful.Consumer removed the bandage from his daughter and stated the application site of pad was ruptured.The consumer (father) took his daughter to the hospital and she was prescribed an unknown ointment.Consumer stated the insect bite became a scab and is resolving.This is 2 of 2 med-watches being submitted as two devices were involved in this event.See medwatch 2214133-2020-00012.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.Corrected data: d1 d4 upc: 4901730075558, lot number: 180305c udi: (b)(4).G1,2 d1, d2, d3, d4: this report is for (band-aid clear strips 10 ap 4901730075558 3730211102apa).Device is not distributed in the united states but is same similar device marketed in the usa (bab perfect blend clear light asst 45s usa 381370057017 8137005701usd).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 march 5, 2018.This is 2 of 2 follow-up med-watches being submitted as two devices were involved in this event.See medwatch 2214133-2020-00012.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.

• Brand Name: BAND-AID CLEAR STRIPS 10 AP
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC.; 199 grandview road; skillman NJ 08558 9418
• MDR Report Key: 9877837
• MDR Text Key: 196409557
• Report Number: 2214133-2020-00013
• 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,foreign
• Type of Report: Initial,Followup
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4901730075558
• Device Lot Number: 180305C
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 04/01/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR