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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRIMUS MEDICAL LLC PRIME PLUS BARIATRIC MATTRESS
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PRIMUS MEDICAL LLC PRIME PLUS BARIATRIC MATTRESS Back to Search Results
Model Number PPBN546
Device Problems Degraded (1153); Delamination (2904); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/27/2014
Event Type  malfunction  
Event Description
Upon receipt of the recall packet, the customer notified the firm that their customer had a delaminated mattress.
 
Manufacturer Narrative
Upon review of pictures sent from the customer, the urethane cover bubbled at the head section of the mattress exposing the inside of the top cover of the mattress.A new mattress was shipped to the customer on (b)(6) 2014.This problem has been assigned to capa # (b)(4) and a follow up report will be submitted upon completion of the corrective action.
 
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Brand Name
PRIME PLUS BARIATRIC MATTRESS
Manufacturer (Section D)
PRIMUS MEDICAL LLC
boardman OH
Manufacturer Contact
mark hudson
5850 klockner drive
richmond, VA 23231
8042261155
MDR Report Key4253133
MDR Text Key16305605
Report Number3007538326-2014-00142
Device Sequence Number1
Product Code IKY
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 11/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberPPBN546
Device Catalogue NumberSP02-PPBM546
Device Lot Number032713
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/27/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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