MAUDE Adverse Event Report: PRIMUS MEDICAL LLC PRIME CARE (R) TRANSCEND MATTRESS

Model Number TCM3580

Device Problems Degraded (1153); Delamination (2904); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/08/2015

Event Type  malfunction  

Event Description

Customer emailed stating they had a mattress that delaminated.

Manufacturer Narrative

Upon review of the pictures sent from the customer, the center and foot end of the urethane cover bubbled up and peeled away, exposing the inside of the mattress cover.A new mattress was shipped out to the customer.This problem has been assigned to capa (b)(4), and a follow-up report will be submitted upon completion of the corrective action.

• Brand Name: PRIME CARE (R) TRANSCEND MATTRESS
• Manufacturer (Section D): PRIMUS MEDICAL LLC; boardman OH
• Manufacturer Contact: mark hudson ; 5850 klockner; richmond, VA 23231 ; 8042261155
• MDR Report Key: 4942334
• MDR Text Key: 6034551
• Report Number: 3007538326-2015-00048
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: TCM3580
• Device Catalogue Number: SP03-TCM3580
• Device Lot Number: 041812
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-2596-2014
• Patient Sequence Number: 1