MAUDE Adverse Event Report: BLICKMAN INDUSTRIES LLC WARMING CABINET BW7924TG; WARMER, IRRIGATION SOLUTION

Model Number 7924TG

Device Problem Sharp Edges (4013)

Patient Problem Laceration(s) (1946)

Event Date 07/06/2020

Event Type  Injury  

Manufacturer Narrative

This blanket warmer was not manufactured by blickman industries llc.Blickman industries, llc, acquired the operating assets of blickman, inc.On december 21, 2017.Specifically, the purchase agreement required blickman inc.To retain responsibility for all previously distributed products.Blickman industries, llc maintains reporting responsibility for the medical devices manufactured and distributed by blickman industries, llc.Blickman industries, llc will abide with the reporting requirements for this observation, but that based on the fda medical device reporting requirements, we do not retain responsibility.This is supported by fda medical device reporting for manufacturers.Guidance for industry and food and drug administration staff.Document issued on: november 8.2016.Section 4.12 manufacturer ceased marketing a device.Blickman inc.Implemented an improved deburring step to bw manufacturing on 05-26-11.The intention of this additional step was to further reduce the probability that a sharp edge could occur during the punch-hole process.

Event Description

(b)(6) reported, "i just got a call from (b)(6) from (b)(6).He said that he received some complaints about nurses getting cut from the side vents when using the blanket warmer.He had not checked that warmer in question but was able to confirm very sharp edges on a separate warmer.".

• Brand Name: WARMING CABINET BW7924TG
• Type of Device: WARMER, IRRIGATION SOLUTION
• Manufacturer (Section D): BLICKMAN INDUSTRIES LLC; 500 us highway #46 east; clifton NJ 07011
• Manufacturer (Section G): BLICKMAN INC.; 3252 east loop n. eastport; industrial park, bldg 6; houston TX 77029
• Manufacturer Contact: jeffrey young ; 500 us highway #46 east; clifton, NJ 07011 ; 9733300571
• MDR Report Key: 12440769
• MDR Text Key: 270508222
• Report Number: 0002244019-2021-00001
• Device Sequence Number: 1
• Product Code: LHC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7924TG
• Device Catalogue Number: 14B7924243
• Device Lot Number: 007334, 007605
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 09/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2010
• 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
• Patient Outcome(s): Required Intervention