VEST MODEL 105 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-06-15 for VEST MODEL 105 NA manufactured by Hill-rom Services Private Limited.

Event Text Entries

[2762094] Hill-rom has rec'd a report from a pt alleging that the vest may have caused her breast implants to rupture. No device malfunction was alleged nor discovered through subsequent analysis.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3008145987-2012-00002
• MDR Report Key: 2624571
• Report Source: 04
• Date Received: 2012-06-15
• Date of Report: 2012-05-17
• Date of Event: 2011-12-01
• Date Mfgr Received: 2012-05-17
• Device Manufacturer Date: 2010-08-21
• Date Added to Maude: 2012-06-22
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: BRICE RICKER
• Manufacturer Phone: 8437408440
• Manufacturer G1: HILL-ROM CHARLESTON
• Manufacturer Street: 4349 CORPORATE DRIVE
• Manufacturer City: CHARLESTON SC 29405
• Manufacturer Country: US
• Manufacturer Postal Code: 29405
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: VEST MODEL 105
• Generic Name: POWERED PERCUSSOR
• Product Code: BYI
• Date Received: 2012-06-15
• Returned To Mfg: 2012-06-08
• Model Number: 105
• Catalog Number: NA
• Lot Number: NA
• ID Number: NA
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: HILL-ROM SERVICES PRIVATE LIMITED
• Manufacturer Address: 1 YISHUN AVENUE 7 SINGAPORE SN

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2012-06-15