RF DESIGN VS11702

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-05-02 for RF DESIGN VS11702 manufactured by Rf Design, Inc..

Event Text Entries

[2752694] During scheduled annual maintenance (done one month earlier than scheduled) on lead aprons/vests, four lead aprons/vests were found to have significant damage. All four of the aprons were less then one year old. Both the tech and the vendor reported said that in over twenty years they have never seen damage like this before. There were multiple gaping tears in odd places (i. E. Thyroid & groin area). The users of the lead aprons/vests cared for them per manufacturer instructions. Each of the four aprons/vests have a different number based on color and size. Our radiation safety officer will be conducting dosimetry radiation badge reviews for each person involved. The lead aprons/vests were returned to the vendor for evaluation and have since been replaced. Of note: older apron/vests have not shown this level of damage. The on site rep indicated that he had not seen damage such as this before and replaced all four lead devices.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2561627
• MDR Report Key: 2561627
• Date Received: 2012-05-02
• Date of Report: 2012-05-02
• Date of Event: 2012-04-12
• Report Date: 2012-05-02
• Date Reported to FDA: 2012-05-02
• Date Added to Maude: 2012-05-07
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: RF DESIGN
• Generic Name: X-RAY SHIELD, PROTECTIVE, PERSONAL
• Product Code: KPY
• Date Received: 2012-05-02
• Returned To Mfg: 2012-04-21
• Model Number: VS11702
• Catalog Number: VS11702
• Lot Number: *
• ID Number: *
• Device Availability: R
• Device Age: 1 YR
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: RF DESIGN, INC.
• Manufacturer Address: 10143 BERGIN RD. HOWELL MI 48843 US 48843

Device Sequence Number: 2

• Brand Name: RF DESIGN
• Generic Name: X-RAY SHIELD, PROTECTIVE, PERSONAL
• Product Code: KPY
• Date Received: 2012-05-02
• Returned To Mfg: 2012-04-21
• Model Number: VS11701
• Catalog Number: VS11701
• Lot Number: *
• ID Number: *
• Device Availability: R
• Device Age: 1 YR
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: RF DESIGN, INC.
• Manufacturer Address: 10143 BERGIN RD. HOWELL MI 48843 US 48843

Device Sequence Number: 3

• Brand Name: RF DESIGN
• Generic Name: X-RAY SHIELD, PROTECTIVE, PERSONAL
• Product Code: KPY
• Date Received: 2012-05-02
• Returned To Mfg: 2012-04-21
• Model Number: VS11701
• Catalog Number: VS11701
• Lot Number: *
• ID Number: *
• Device Availability: R
• Device Age: 1 YR
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: RF DESIGN, INC.
• Manufacturer Address: 10143 BERGIN RD. HOWELL MI 48843 US 48843

Device Sequence Number: 4

• Brand Name: RF DESIGN
• Generic Name: X-RAY SHIELD, PROTECTIVE, PERSONAL
• Product Code: KPY
• Date Received: 2012-05-02
• Returned To Mfg: 2012-04-21
• Model Number: EB601
• Catalog Number: EB601
• Lot Number: *
• ID Number: *
• Device Availability: R
• Device Age: 1 YR
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: RF DESIGN, INC.
• Manufacturer Address: 10143 BERGIN RD. HOWELL MI 48843 US 48843

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-05-02