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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: O&M HALYARD, INC. GORILLA BAG WRAP, STERILIZATION

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O&M HALYARD, INC. GORILLA BAG WRAP, STERILIZATION Back to Search Results
Device Problems Device Emits Odor (1425); Defective Component (2292)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/11/2020
Event Type  malfunction  
Event Description
Wet sterilization pack; healthmark industries co makes a "gorilla bag" this bag is designed offer extra protection to sterile instrument sets. It states in the ifu that these bags can be sterilized, they don't work, when you open the set it is full of water and a bad smell. On researching this product further it is sold with sterilization parameters, but never went thru 510k process, no clearance can be found and company says they don't need it. How can it not be 510k needed if you give out instructions to steam sterilization, this goes against everything. I have been taught and i have been doing this for 20 years. Please also note it rates this device for 19 pounds of instruments, sterilizers are rated for 17 pounds [old ones] and 25 pounds [new ones] why make a product that doesn't fit sterilizer manufacture ifu's? please follow up on this halyard blue sterilization wrap, cardinal and medline all have 510k why not this product?; dates of use: (b)(6) 2020 - (b)(6) 2020. It was suppose to protect sterile instruments; comes in multiple sizes and code. Fda safety report id# (b)(4).
 
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Brand NameGORILLA BAG
Type of DeviceWRAP, STERILIZATION
Manufacturer (Section D)
O&M HALYARD, INC.
MDR Report Key10188867
MDR Text Key196770640
Report NumberMW5095162
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 06/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 06/23/2020 Patient Sequence Number: 1
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