MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; PATIENT GOWN

Catalog Number MDTPG5RTSDEMZ

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Asphyxia (1851)

Event Date 08/28/2016

Event Type  Death  

Event Description

Entered resident's room to give meds and saw he wasn't in bed, found him sitting on floor with his head down and noticed his gown strings in the back were caught on the side rail.I could tell he was deceased, i felt no pulse.

• Brand Name: MEDLINE
• Type of Device: PATIENT GOWN
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 5948844
• MDR Text Key: 54710872
• Report Number: 5948844
• Device Sequence Number: 1
• Product Code: FME
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MDTPG5RTSDEMZ
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2016
• Distributor Facility Aware Date: 08/28/2016
• Device Age: 1 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 09/13/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2016
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 81 YR
• Patient Weight: 89