MAUDE Adverse Event Report: PRIMUS MEDICAL LLC PRIME PLUS (R) BARIATRIC MATTRESS

Model Number PPBM486

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

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

Event Date 10/30/2014

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 picture sent from the customer the urethane cover bubbled at the center of the mattress but did not expose the inside of the mattress cover or the foam inside the mattress.A new mattress is due to ship to the customer on (b)(6) 2014.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 PLUS (R) BARIATRIC MATTRESS
• Manufacturer (Section D): PRIMUS MEDICAL LLC; boardman OH
• Manufacturer Contact: mark hudson ; 5850 klockner dr.; richmond, VA 23231 ; 8042261155
• MDR Report Key: 4293904
• MDR Text Key: 20070496
• Report Number: 3007538326-2014-00143
• 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: 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 Number: PPBM486
• Device Catalogue Number: SP02-PPBM486
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/30/2014
• Initial Date FDA Received: 11/26/2014
• 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 Number: Z-2596-2014
• Patient Sequence Number: 1