MAUDE Adverse Event Report: PRISM MEDICAL P300/P440 CARRY BAR; NONE

Device Problem Material Frayed (1262)

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

Event Date 06/24/2015

Event Type  malfunction  

Manufacturer Narrative

The defective item has been requested to evaluate.Should it be received and updated report will be submitted to reflect all findings.

Event Description

Strap on carry bar fraying.

• Brand Name: P300/P440 CARRY BAR
• Type of Device: NONE
• Manufacturer (Section D): PRISM MEDICAL; maryland heights MO 63043
• Manufacturer Contact: steve kilburn ; 10888 metro ct.; maryland heights, MO 63043 ; 3142198614
• MDR Report Key: 4959973
• MDR Text Key: 22460953
• Report Number: 3007802293-2015-00028
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Report Date: 07/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/24/2015
• 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: Reuse
• Patient Sequence Number: 1