MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP NEPTUNE DOCKING DETERGENT; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Catalog Number 0700001026

Device Problems Fluid/Blood Leak (1250); Fumes or Vapors (2529)

Patient Problems Rash (2033); Caustic/Chemical Burns (2549); Skin Burning Sensation (4540)

Event Date 08/19/2022

Event Type  malfunction  

Event Description

Per the customer an employee was cleaning the floor area using towels and exposed their skin to detergent that was on the towel being used to clean the floor.The arm exposed to the detergent had a reaction of skin bubbling and a burning sensation.Per the customer there is no record of any medical intervention that was administered for the event at the user facility.Attempts are being made to obtain additional information from the user facility.

Event Description

Per the customer an employee was cleaning the floor area using towels and exposed their skin to detergent that was on the towel being used to clean the floor.The arm exposed to the detergent had a reaction of skin bubbling and a burning sensation.Upon follow up, the user facility was not able to provide any further information regarding the reported event.

Manufacturer Narrative

After further clarification of the potential risk and harm for the event, this record is being filed to denote that 3015967359-2022-01787 was filed in error.The reported malfunction is not a reportable event.H3 other text : device not returned.

• Brand Name: NEPTUNE DOCKING DETERGENT
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 15441878
• MDR Text Key: 300325442
• Report Number: 3015967359-2022-01787
• Device Sequence Number: 1
• Product Code: FYD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 01/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 0700001026
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/19/2022
• Initial Date FDA Received: 09/16/2022
• Supplement Dates Manufacturer Received: 01/16/2023
• Supplement Dates FDA Received: 01/16/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1