MAUDE Adverse Event Report: HARBOR SAFETY PRODUCTS SHARPTRAP SHARPS CONTAINER

Model Number ST100

Device Problem Material Integrity Problem (2978)

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

Event Date 01/01/2016

Event Type  malfunction  

Event Description

Reporter states product is not fda approved.He states the product doesn't look safe and he can easily insert his hand into the container.

• Brand Name: SHARPTRAP SHARPS CONTAINER
• Type of Device: SHARPTRAP SHARPS CONTAINER
• Manufacturer (Section D): HARBOR SAFETY PRODUCTS; 5312 17th nw; seattle WA 98107
• MDR Report Key: 6232373
• MDR Text Key: 64278420
• Report Number: MW5067085
• Device Sequence Number: 1
• Product Code: MMK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ST100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR