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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRIMUS MEDICAL LLC PRIME CARE (R) TRANSCEND MATTRESS
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PRIMUS MEDICAL LLC PRIME CARE (R) TRANSCEND MATTRESS Back to Search Results
Model Number TCM3580
Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/05/2014
Event Type  malfunction  
Event Description
Customer sent an email with photos saying that their customer had a mattress that was delaminated.
 
Manufacturer Narrative
Upon review of pictures sent from the customer the urethane cover bubbled at the center and foot end of the mattress exposing the inside of the mattress cover.A new mattress is due to ship to the customer on (b)(4) 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 CARE (R) TRANSCEND MATTRESS
Manufacturer (Section D)
PRIMUS MEDICAL LLC
boardman OH
Manufacturer Contact
mark hudson
5850 klockner dr.
richmond, VA 23231-0000
8042261155
MDR Report Key4293917
MDR Text Key5270127
Report Number3007538326-2014-00147
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
Remedial Action Recall
Type of Report Initial
Report Date 11/24/2014
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? No
Device Operator Other
Device Model NumberTCM3580
Device Catalogue NumberSP03-TCM3580
Device Lot Number042012
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/05/2014
Initial Date FDA Received11/26/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2012
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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