BLIZZARD 3 LAYER TRAUMA BLANKET

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-17 for BLIZZARD 3 LAYER TRAUMA BLANKET manufactured by Persys Medical.

Event Text Entries

[184515435] Product: class 1 medical device, blizzard blanket bps-01, website (b)(6). Persys medicals use false marketing in the tog value to the blizzard product. They say that tog value is 7 which means to customers that the product is the same like winter sleeping bag and it can lead customers in the danger if they think that you can sleep in the winter with this product like winter sleeping bag. They also distort competition between companies which set the hypothermia product. Here is certificate bttg test report ((b)(6)-blizzard under the tension) results and the university of (b)(6) report results were you can see the difference certificated bttg test report (b)(6) use the same standard that (b)(6) university (standard bs4745), but the results are pretty different in the blizzard (2. 02 ->6. 6). In the (b)(6) report they also say that they have use bs en 12127:1998 standard to calculate mass per unit value. This standard is intended to determine the weight variation of a clothes. So they use misleading standards that have nothing to do with these products and can figure number to the product what they went. Also here you can see the other report of the university of (b)(6) (university of (b)(6) tog testing) which persys medical /blizzard based on their "tog 7 - marketing". This test report is obviously false. If you check the test report, it says that woman and children sleep well in the -12. 7 degrees (comfort value), man sleep well in the 2. 1 degrees (limit value) and hypothermia threat in the blizzard bag in 6. 8 degrees (extreme value). Report has made by (b)(6) which doesn't answer the questions of these studies if you tried to contact him. Blizzard use this data to marketing their product but they have changed the hypothermia terms in the marketing sheet (limit value, comfort value and extreme value). The terms are not the same in the test report and the advertisements. Blizzard hypothermia product is widely used around the world. In the us, for example, the military uses the product. It is such equal like every hypothermia product to prevent hypothermia. However, advertising value of the tog 7, they mislead customers to believe that is compared to equal as sleeping bags. (b)(6). Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5093832
• MDR Report Key: 9848324
• Date Received: 2020-03-17
• Date of Report: 2020-03-15
• Date of Event: 2020-03-14
• Date Added to Maude: 2020-03-18
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BLIZZARD 3 LAYER TRAUMA BLANKET
• Generic Name: SYSTEM, THERMAL REGULATING
• Product Code: DWJ
• Date Received: 2020-03-17
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PERSYS MEDICAL
• Manufacturer Address: 5310 ELM ST. HOUSTON TX 77081 US 77081

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-03-17