MAUDE Adverse Event Report: HOSPITAL BED MATTRESS; HOSPITAL BED AC-POWERED

Device Problems Hole In Material (1293); Material Protrusion/Extrusion (2979)

Patient Problems Diarrhea (1811); Pain (1994); Vomiting (2144); Viral Infection (2248); Discomfort (2330); Sleep Dysfunction (2517)

Event Date 12/20/2016

Event Type  Injury  

Event Description

My husband, disabled son, and i traveled from our home in (b)(6) to our daughter's home in (b)(6).We rented an electric hospital bed from (b)(6).We arrived very late on (b)(6) 2016 and got our son (who has duchenne muscular dystrophy) on the hospital bed to go to sleep.The mattress was very bumpy and uncomfortable.My son could feel springs in different places.This was even after i put a soft mattress pad and sheets on the bed.He had a very fitful and painful night.The next morning we took the sheets off of the mattress to inspect it.We were stunned to see holes in areas and visible metal springs through the holes! we were very concerned about infection due to the breach in the vinyl covering of the mattress and also the extreme discomfort of this mattress.My husband called (b)(6) and spoke to (b)(6).He said that he wouldn't be able to deliver a replacement mattress until the next day.My husband said that there was no way my son could sleep on that mattress again.He advised (b)(6) that we were going to have to go out and buy a mattress.My husband and daughter went to 5 stores to find a mattress that we could purchase and bring home the same day.(b)(6) refused to refund our money.We have filed a dispute with the credit card company.My husband and son became ill with a terrible stomach virus involving vomiting and diarrhea.We have to wonder if the source of the illness could have been from the damaged mattress.

• Brand Name: HOSPITAL BED MATTRESS
• Type of Device: HOSPITAL BED AC-POWERED
• MDR Report Key: 6228314
• MDR Text Key: 64161768
• Report Number: MW5067080
• Device Sequence Number: 1
• Product Code: FNL
• 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: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 27 YR
• Patient Weight: 52