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

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 03/11/2015

Event Type  malfunction  

Event Description

Upon receipt of the recall packet and follow up to the customer the firm was notified that the customer had a delaminated mattress.

Manufacturer Narrative

Upon review of the mattress the urethane cover bubbled and peeled away at the center of the mattress exposing the inside of the top cover.A new mattress was delivered out to the customer on 03/11/2015.This problem has been assigned to capa (b)(4), and a following up report will be submitted upon completion of the corrective action.

• Brand Name: PRIME CARE (R) TRANSCEND MATTRESS
• Type of Device: IKY
• Manufacturer (Section D): PRIMUS MEDICAL LLC; boardman OH
• Manufacturer Contact: mark hudson ; 5850 klockner dr.; richmond, VA 23231 ; 8042261155
• MDR Report Key: 4680362
• MDR Text Key: 16989597
• Report Number: 3007538326-2015-00017
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/03/2015

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 Number: TCM3580
• Device Catalogue Number: SP03-TCM3580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/11/2015
• Initial Date FDA Received: 04/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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