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

Model Number MDR107002E

Device Problem Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Date 12/09/2022

Event Type  Injury  

Event Description

According to the customer, on (b)(6) 2022, the remote to the bed "melted and started to smoke causing a burn on her lower back".

Manufacturer Narrative

According to the customer, on (b)(6) 2022, the remote to the bed "melted and started to smoke causing a burn on her lower back".The customer reported she uses the bed daily, the bed "will not go down", and she has been sleeping in an "upright position".The customer reported the skin is intact where the burn occurred and she is letting it "heal on its own".According to the customer there was no medical intervention required and no serious injury identified at this point.The device is available but has not been returned for evaluation.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: Medline
• Type of Device: BED,BASIC, SEMI ELECTRIC
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16070800
• MDR Text Key: 306362393
• Report Number: 1417592-2022-00248
• Device Sequence Number: 1
• Product Code: LLI
• 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
• Report Date: 12/29/2022

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 Model Number: MDR107002E
• Device Catalogue Number: MDR107002E
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/09/2022
• Initial Date FDA Received: 12/29/2022
• 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
• Patient Sex: Female