MAUDE Adverse Event Report: PRIMUS MEDICAL, LLC PRIME CARE (R) TRANSCED BASIC MATTRESS

Model Number TCBM3580

Device Problem Leak/Splash (1354)

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

Event Date 08/05/2014

Event Type  malfunction  

Event Description

Customer sent an email stating that the mattress sealant was leaking.

Manufacturer Narrative

Upon inspection of this mattress, the nylon cover delaminated from the inside out at the center of the mattress.There is no lot number to this mattress.A new mattress was delivered to the facility on (b)(4) 2014.This mattress has been quarantined until further investigation.A follow-up report will be submitted upon completion of the investigation and/or corrective action.

• Brand Name: PRIME CARE (R) TRANSCED BASIC MATTRESS
• Manufacturer (Section D): PRIMUS MEDICAL, LLC; boardman OH
• Manufacturer Contact: mark hudson ; 5850 klockner dr; richmond, VA 23231 ; 8042261155
• MDR Report Key: 4099154
• MDR Text Key: 15121320
• Report Number: 3007538326-2014-00071
• 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
• Type of Report: Initial
• Report Date: 08/28/2014

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: TCBM3580
• Device Catalogue Number: SP03-TCB3580
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/06/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/05/2014
• Initial Date FDA Received: 09/03/2014
• 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
• Patient Sequence Number: 1