MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; BEDPAN

Catalog Number NOVA10145

Device Problem Collapse (1099)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 08/01/2016

Event Type  Injury  

Manufacturer Narrative

It was reported that the bedpan collapsed when the nurse placed a post op burn patient on it in the pacu.As a result, urine spilled in the bed and caused her new surgical dressings to become wet.The surgeon came and replaced the dressings.No other information was provided.The weight of the patient is not known.The sample was not returned for evaluation.A root cause has not been determined.

Event Description

The bedpan collapsed under the patient causing the surgical dressing to become wet.

• Type of Device: BEDPAN
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 5901660
• MDR Text Key: 52946410
• Report Number: 1417592-2016-00091
• Device Sequence Number: 1
• Product Code: FOB
• 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,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Catalogue Number: NOVA10145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 08/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR