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

Model Number PPBM427

Device Problems Nonstandard Device (1420); Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 08/25/2014

Event Type  malfunction  

Event Description

Upon receipt of the recall packet, the customer notified the firm that they had a delaminated mattress.

Manufacturer Narrative

Upon review of the pictures of the mattress sent from the customer, the urethan cover bubbled throughout the entire mattress exposing the foam of the mattress.A new mattress was sent out 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 23231-0000 ; 8042261155
• MDR Report Key: 4202977
• MDR Text Key: 4963658
• Report Number: 3007538326-2014-00104
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/17/2014

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?: Yes
• Device Operator: Other
• Device Model Number: PPBM427
• Device Catalogue Number: SP02-PPBM427
• Device Lot Number: 032713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/25/2014
• Initial Date FDA Received: 09/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• 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