MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO S3 EX - 3005; BED, AC-POWERED ADJUSTABLE HOSPITAL

Catalog Number 3005S3EX

Device Problem Scratched Material (3020)

Patient Problem Tissue Damage (2104)

Event Date 02/03/2016

Event Type  Injury  

Event Description

It was reported that bolts on the crossbar had exposed sharp edges that allegedly cut the housekeeper's finger.No additional information has been provided.

Manufacturer Narrative

Follow-up submitted with evaluation results which determined there was no product malfunction.No injuries were reported.The customer dissatisfaction was with bolts under the fowler being exposed potentially leading to house keepers cutting their hands when cleaning.Cleaning methods were discussed with the customer.

Event Description

It was reported that bolts on the crossbar had exposed sharp edges that allegedly cut the housekeeper's finger.No additional information has been provided.

• Brand Name: S3 EX - 3005
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: rita moffitt ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 5480127
• MDR Text Key: 39664942
• Report Number: 0001831750-2016-00078
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 3005S3EX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1