MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND KPP BANDAGES; ADHESIVE BANDAGE

Model Number 4901730077699

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

Patient Problem Foreign Body In Patient (2687)

Event Date 04/09/2019

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient identifier, sex, weight, ethnicity, race: patient identifier, sex, weight, patient ethnicity and race were not provided.Brand name, common device name, procode, mfr, lot #, part #, udi #: this report is for ((b)(6) brand kpp spot 10s 2015 ap).Device is not distributed in the united states, but is similar to device marketed in the usa ((b)(6) brand hydroseal bandages all purpose 1ct usa usa 381371175338).Device available for evaluation: device is not expected to be returned for manufacturer review/investigation device evaluated by mfr, manufacture date: device evaluation 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.A supplemental report will be provided if any additional information is received.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 in (b)(6) reported an event with (b)(6) brand kpp spot 10s.The kpp was applied for a scratch on her breast.The consumer alleged that her nine month old baby swallowed the product during breast feeding.The baby was normal at the time of the report and there is no indication of medical intervention or treatment performed for this event.

• Brand Name: BAND AID BRAND KPP BANDAGES
• Type of Device: ADHESIVE BANDAGE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview avenue; skillman NJ 08558 9418
• Manufacturer (Section G): COLOPLAST; coloplast hungary kft.; h-4300 nyirbator; coloplast u.2 ; HU
• Manufacturer Contact: linda plews ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152737120
• MDR Report Key: 8578511
• MDR Text Key: 143987878
• Report Number: 2214133-2019-00073
• 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
• Report Date: 04/09/2019

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: 4901730077699
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 05/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 9 MO