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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HANGZHOU SPECIAL NONWOVENS CO. LTD. BLOOM BABY WIPES DISINFECTANT, MEDICAL DEVICES

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HANGZHOU SPECIAL NONWOVENS CO. LTD. BLOOM BABY WIPES DISINFECTANT, MEDICAL DEVICES Back to Search Results
Lot Number 111488
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/03/2018
Event Type  malfunction  
Event Description
I opened a package of bloom baby wipes and they were covered in black mold. I placed a complaint online since i purchased them on (b)(6). I also called the manufacturer us nonwovens and filed a complaint. No one has called back to get information from me to investigate. I still have the package with codes and product.
 
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Brand NameBLOOM BABY WIPES
Type of DeviceDISINFECTANT, MEDICAL DEVICES
Manufacturer (Section D)
HANGZHOU SPECIAL NONWOVENS CO. LTD.
602 rockwood rd.
wilmington DE 19802
MDR Report Key8160585
MDR Text Key130466644
Report NumberMW5082093
Device Sequence Number1
Product Code LRJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number111488
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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