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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRIMUS MEDICAL, LLC PRIME CARE (R) TRANSCEND BASIC MATTRESS
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PRIMUS MEDICAL, LLC PRIME CARE (R) TRANSCEND BASIC MATTRESS Back to Search Results
Model Number TCBM3580P
Device Problems Delamination (2904); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/11/2014
Event Type  malfunction  
Event Description
Customer called in stating that they had a mattress that looked like it was delaminating.
 
Manufacturer Narrative
Upon inspection of this mattress, the nylon cover delaminated from the inside out at the center of the mattress allowing the fluid to enter the foam of the mattress.A new mattress was delivered to the facility on (b)(4) 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 (R) TRANSCEND BASIC MATTRESS
Manufacturer (Section D)
PRIMUS MEDICAL, LLC
boardman OH
Manufacturer Contact
mark hudson
5850 klockner dr.
richmond, VA 23231
8042261155
MDR Report Key4173072
MDR Text Key5091317
Report Number3007538326-2014-00119
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 10/01/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberTCBM3580P
Device Catalogue NumberSP03-TCBM3580P
Device Lot Number060512
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer09/12/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/11/2014
Initial Date FDA Received10/10/2014
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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