MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND KIZU POWER PAD; DRESSING, WOUND, OCCLUSIVE

Model Number 4901730021906

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

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient identifier, gender, weight, and ethnicity and race were not provided for reporting.This report is for (band aid brand kizu power pad regular ap (b)(4) 0037131785apa 0037131785apa).Device is not distributed in the united states, but is similar to device marketed in the usa (band aid brand hydroseal bandages all purpose 1ct usa 381371175338 8137117533usa 8137117533usa).Udi# (b)(4).Upc-(b)(4).Lot number- ni.Exp date- na.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 brand hydroseal bandages all purpose 1ct usa 381371175338 8137117533usa 8137117533usa).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.At this time, with limited information provided, this event is being reported with an overabundance of caution.Failure to following instructions: packaging instruction for use states: to keep the product out of reach of children.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

An individual (reporter) from (b)(6) reported that a (b)(6) baby (consumer) swallowed a band aid brand kizu power pad regular(kpp).The reporter stated that kpp was not used for the consumer.The consumer accidentally swallowed kpp.The reporter took the consumer to a hospital about 30 minutes after swallowing the product.The reporter was told that there was no problem because the consumer had no abnormal symptom and kpp was not stuck in the bronchi.According to the reporter, no treatment was given to the consumer, and the reporter was told that the kpp would be expelled through the anus.There was no additional information provided and no mention of intervention.

• Brand Name: BAND AID BRAND KIZU POWER PAD
• Type of Device: DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview rd; skillman NJ 08558 9418
• Manufacturer (Section G): COLOPLAST; coloplast hungary kft.; h-4300 nyirbator; coloplast u.2 ; HU
• Manufacturer Contact: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 11761304
• MDR Text Key: 264334196
• Report Number: 2214133-2021-00016
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 4901730021906
• UDI-Public: (01)4901730021906(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
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4901730021906
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 04/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 10 MO