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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OWENS AND MINOR HUGGIES LITTLE SNUGGLERS SIZE 1, 8-14 LBS

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OWENS AND MINOR HUGGIES LITTLE SNUGGLERS SIZE 1, 8-14 LBS Back to Search Results
Lot Number BI427617B
Device Problems Material Disintegration (1177); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/21/2015
Event Type  malfunction  
Event Description
Sharp metal shavings/shards discovered embedded in the fibers of several huggies little snugglers size 1 8-14 lb diapers. The affected diapers appear to be isolated to the same lot number. We have had one staff member poked and one pt poked as a result without serious harm or injury. Our facility is currently removing all known supply of this lot number from stock. Unk if any other lot numbers are affected at this time. Dates of use: (b)(6) 2014 to (b)(6) 2015. Reason for use: infant waste elimination storage product. Event abated after use stopped.
 
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Brand NameHUGGIES LITTLE SNUGGLERS
Type of DeviceSIZE 1, 8-14 LBS
Manufacturer (Section D)
OWENS AND MINOR
MDR Report Key4494785
MDR Text Key5564500
Report NumberMW5040625
Device Sequence Number1
Product Code EYQ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 01/23/2015
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/04/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Lot NumberBI427617B
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes

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