MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO NARA, DOMESTIC; BASSINET, HOSPITAL

Catalog Number 4402000001

Device Problem Use of Device Problem (1670)

Patient Problem Injury (2348)

Event Date 01/02/2019

Event Type  Injury  

Event Description

It was reported an injury occurred on a sharp edge of the bassinet.No additional information is yet known regarding the severity of the reported injury.

Manufacturer Narrative

During investigation, it was determined that this event is the same event as was reported in 0001831750-2019-00605.Since the filing of this initial mdr, stryker medical received a u.S.Consumer product safety commission report that a caregiver was injured by a stryker nara bassinet when it rolled into the back of her left ankle, with the caregiver reportedly sustaining a 5 inch long by 3 inch wide laceration that required stitches.It is also reported that the injury resulted in a neuroma, neuropathy, nerve damage as well as a contracture on the caregiver's leg.The device involved in the reported event was not available for evaluation, as the serial number was not recorded.Additionally, upon reaching out to the user facility, they indicated they had no incident report for the alleged event, and could therefore not provide any details.The serial number of the device was not recorded.

Event Description

It was reported an injury occurred on a sharp edge of the bassinet.No additional information is yet known regarding the severity of the reported injury.

• Brand Name: NARA, DOMESTIC
• Type of Device: BASSINET, 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: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 8286859
• MDR Text Key: 134408703
• Report Number: 0001831750-2019-00262
• Device Sequence Number: 1
• Product Code: NZG
• UDI-Device Identifier: 07613327261615
• UDI-Public: 07613327261615
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 4402000001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/02/2019
• Was Device Evaluated by Manufacturer?: No
• 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