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

Catalog Number	4402000001
Health Effect - Clinical Codes	Laceration(s) (1946); Nerve Damage (1979); Neuropathy (1983)
Date of Event	04/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Serial number of the unit was not reported.
Event or Problem Description
It was reported via 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.
Additional Manufacturer Narrative
During investigation, it was determined this event had been previously reported in mdr 0001831750-2019-00262.
Event or Problem Description
It was reported via 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.

• Brand Name: NARA, DOMESTIC
• Common Device Name: BASSINET, HOSPITAL
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 8758498
• Report Number: 0001831750-2019-00605
• Device Sequence Number: 1680380
• Product Code: NZG
• UDI-Device Identifier: 07613327261615
• UDI-Public: 07613327261615
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Catalogue Number: 4402000001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/05/2019
• Supplement Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 08/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR