MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; BED,BASIC, SEMI ELECTRIC

Catalog Number MDR107002E

Device Problem Material Integrity Problem (2978)

Patient Problem Pressure Sores (2326)

Event Date 07/27/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer, the mattress has a "crater-like sinkhole" under her father's sacrum.The customer reported the "springs under the sacrum area" have "sunk down" worsening the "sink hole".The customer reported there was a pre-existing wound on his sacrum that was "scabbed over" and it has now "opened up".The customer reported there are new wounds developing on "both of his ankles and his calf" that are becoming deeper in depth.The customer reported her father is terminally ill and has nurses coming to clean the wounds, apply "hydrogen peroxide" and "neosporin", and change the dressings every 2 days.The customer reported her father has "pressure relieving cushions" he is using and is being turned every "2 to 3 hours" during the day but, not at night.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the customer, the mattress has a "crater-like sinkhole" under her father's sacrum.The customer reported the "springs under the sacrum area" have "sunk down" worsening the "sink hole".

Manufacturer Narrative

Investigation conclusions.

• Type of Device: BED,BASIC, SEMI ELECTRIC
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17553459
• MDR Text Key: 321220876
• Report Number: 1417592-2023-00342
• Device Sequence Number: 1
• Product Code: LLI
• UDI-Device Identifier: 40080196320999
• UDI-Public: 40080196320999
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDR107002E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/27/2023
• Initial Date FDA Received: 08/15/2023
• Supplement Dates Manufacturer Received: 09/19/2023
• Supplement Dates FDA Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other