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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRIMUS MEDICAL LLC PRIME CARE TRNASCENT BASIC PER. MATTRESS
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PRIMUS MEDICAL LLC PRIME CARE TRNASCENT BASIC PER. MATTRESS Back to Search Results
Model Number TCBM3580P
Device Problems Degraded (1153); Delamination (2904); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/17/2014
Event Type  malfunction  
Event Description
Customer called in stating that they had a mattress with the cover leaking and the foam inside was wet.
 
Manufacturer Narrative
Upon inspection of this mattress, the nylon cover delaminated from the inside out at the center of the mattress allowing for fluid to enter the foam of the mattress.A new mattress was delivered to the facility on (b)(6) 2014.This mattress has been quarantined until further investigation.A follow-up report will be submitted upon completion of the investigation and/or corrective action.
 
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Brand Name
PRIME CARE TRNASCENT BASIC PER. MATTRESS
Manufacturer (Section D)
PRIMUS MEDICAL LLC
boardman OH
Manufacturer Contact
mark hudson
5850 klockner drive
richmond, VA 23231-0000
8042261155
MDR Report Key4253155
MDR Text Key4993741
Report Number3007538326-2014-00137
Device Sequence Number1
Product Code IKY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/04/2014
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 NumberTCBM3580P
Device Catalogue NumberSP03-TCBM3580P
Device Lot Number06512
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer10/17/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received10/17/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2012
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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