MAUDE Adverse Event Report: HEALTHMARK INDUSTRIES CO., INC. GORILLA BAG; TRAY, SURGICAL, INSTRUMENT

Device Problems Inadequate Instructions for Healthcare Professional (1319); Moisture Damage (1405); Product Quality Problem (1506); Problem with Sterilization (1596)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/11/2020

Event Type  No Answer Provided  

Event Description

Wet packs can infect pts.Got new product that is supposed to protect sterile instruments.You package as normal and then put in "gorilla bag" from healthmark then sterilize.It doesn't work, makes wet packs.When pack opened has water, came to find out we have ifu for product from company but company never took product through fda 510k when we asked them, they said they don't need it.How is any product used to sterile instruments for surgery not received by 510k? explain why they can sell product that doesn't work.Gorilla bag makes wet packs consistently, we opened all of them.Wet pack caught before pt in room.Ref documents: sterilization wrap(s) conforming to aami/iso 11607, parts 1 and 2, iso/ts 16775.

• Brand Name: GORILLA BAG
• Type of Device: TRAY, SURGICAL, INSTRUMENT
• Manufacturer (Section D): HEALTHMARK INDUSTRIES CO., INC.
• MDR Report Key: 10239161
• MDR Text Key: 197932278
• Report Number: MW5095379
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other