MAUDE Adverse Event Report: SHARPS CONTAINER

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Exposure to Body Fluids (1745); Venipuncture (2129)

Event Date 04/21/2016

Event Type  Other  

Event Description

On (b)(6) 2016 my spouse, (b)(6) and my son, (b)(6) were at an appointment.This appointment was for a follow up on a surgery (b)(6) had performed by this doctor about 6 weeks ago.While they were awaiting the arrival of the doctor into the examining room, (b)(6) experienced a puncture wound on his right hand from a dirty sharp.(b)(6) is a toddler, (b)(6).We feel that circumstances surrounding this event are because the medical hazardous waste container was not stored properly.How else could one explain how a toddler (b)(6) tall is able to reach inside a red sharp storage container and remove a used sharp from it wounding himself multiple times? i have filed a complaint with (b)(6).The representative that took my complaint stated the doctor's office was not in compliance with (b)(6) codes.Is for the benefit of employees and not customer/patients.I would hope that this would be a violation of the fda standard and the (b)(6) as well.The doctor in question was very passe, arrogant and unaccommodating about my son's injury.The doctor offered nothing more than telling us to go see (b)(6) primary care physician for care.We are now using our insurance to provide for (b)(6) treatment and care regarding this matter.Does this seem to be the proper way for a matter like this to be resolved? i would like for the fda and the (b)(6) to review this matter.My son now must undergo a minimum of 12 months of blood tests to be proactive against possible exposure to blood viral infection and pathogens, which may or not have been present from the dirty sharp.This is both a traumatic and stressful experience for all of us, the family.It is going to be time consuming and disappointing all the while.Any assistance and or advice you can or could provide would be greatly appreciated.Thank you, (b)(6).Ps we did file a police report the doctor and office is as follows: thank (b)(6).

• Brand Name: SHARPS CONTAINER
• Type of Device: SHARPS CONTAINER
• MDR Report Key: 5620530
• MDR Text Key: 44383566
• Report Number: MW5061994
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 04/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 13 MO
• Patient Weight: 12