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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 06/11/2015
Event Type  malfunction  
Event Description
Customer emailed that they had a mattress that delaminated.
 
Manufacturer Narrative
Upon review of the picture sent from the customer the urethane cover bubbled at the foot end of the mattress but did not expose the inside of the mattress cover or foam.A new mattress was shipped out of the customer on 06/24/2015.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
8042261155
MDR Report Key4905044
MDR Text Key6534413
Report Number3007538326-2015-00037
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 07/02/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberTCM3580
Device Catalogue NumberSP02-TCM3580
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/11/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction NumberZ-2596-2014
Patient Sequence Number1
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