MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; BED, AC POWERED, ADJUSTABLE HOSPITAL

Catalog Number UNK_MED

Device Problems Insufficient Information (3190); Sharp Edges (4013)

Patient Problems Laceration(s) (1946); Pain (1994)

Event Date 06/18/2021

Event Type  malfunction  

Event Description

It was reported that a user had sustained an ankle injury from an unspecified s3 model bed.No specific device failure has been alleged at this time.Injury details have been requested.No patient involvement was reported.

Manufacturer Narrative

This incident was initially reported as a serious injury, however the investigation identified that it was a minor injury.

Event Description

It was reported that a user had sustained an ankle injury from an unspecified s3 model bed.The injury was stated to be a cut to their ankle but no treatment details were provided.The customer stated that there was no defect with the product but that the user had cut their foot on a sharp metal edge when they had tried to engage the steer pedal and missed.No patient involvement was reported.

• Brand Name: UNKNOWN_MEDICAL_PRODUCT
• Type of Device: BED, AC POWERED, ADJUSTABLE HOSPITAL
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 12175914
• MDR Text Key: 261783667
• Report Number: 0001831750-2021-00984
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNK_MED
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other