JOHNSON & JOHNSON *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-22 for JOHNSON & JOHNSON * manufactured by Johnson & Johnson Consumer Prod Co.

Event Text Entries

[383255] Rptr was very concerned that there appeared to be small crystals or tiny plastic balls being ingested by pt from the nursing pads. The box does not have any warning or statement that there may be a leak in the pads and to be careful to not allow the pt to ingest the material, but instructions for use state to clean the breast before each breastfeeding session. Rptr has noticed the small white beads/balls of material twice; the first time they had thought it was milk and wiped it away but realized the second time. It may have occurred more often without noticing. Pt has experienced acid reflux frequently and rptr is unsure if it may be related to the possible ingestion of this material.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4003805
• MDR Report Key: 562718
• Date Received: 2004-09-22
• Date of Report: 2004-08-10
• Date Added to Maude: 2005-01-04
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: JOHNSON & JOHNSON
• Generic Name: NURSING PADS
• Product Code: NTC
• Date Received: 2004-09-22
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 552450
• Manufacturer: JOHNSON & JOHNSON CONSUMER PROD CO
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2004-09-22