UNSCENTED BABY WIPES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-05 for UNSCENTED BABY WIPES manufactured by Unk.

Event Text Entries

[56800158] I purchased a box of (b)(6) elements baby wipes which i use for diaper changing, wiping my son's hands and face, and other surfaces he might touch. On saturday morning of (b)(6), i pulled a fresh wipe out of a package i was currently using and saw what appeared to be blood and hair on the product. I had used almost all the previous wipes in this package that did not appear to be stained or have hair embedded, the contaminated wipe was one of the last few and i saw the contamination and did not use it on my son. I am very confident that no one in my household had contaminated this wipe. I am very concerned about this unk and potentially bio hazardous material that could have come into contact with my baby. I contacted (b)(6) about this incident and received a reply through email. I am able to send photos and the contaminated product at your request. I will include more info on the packaging of the product here: l16212 17:33 line#72n (b)(6) elements unscented baby wipes 80 count package.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5065228
• MDR Report Key: 6003049
• Date Received: 2016-10-05
• Date of Report: 2016-10-04
• Date of Event: 2016-10-01
• Date Added to Maude: 2016-10-06
• 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 FAMILY MEMBER OR FRIEND
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: UNSCENTED BABY WIPES
• Generic Name: BABY WIPES
• Product Code: LRJ
• Date Received: 2016-10-05
• Lot Number: L16212
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UNK
• Manufacturer Address: UNK UNK

Patients

Patient Number	Treatment	Outcome	Date
1	0		2016-10-05