MAUDE Adverse Event Report: UNKNOWN DLX HND SHWR W/84 IN HOSE AND WALL BRKT 1616700267; ADAPTOR, HYGIENE

Model Number 828-4

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2015

Event Type  malfunction  

Event Description

Reference order (b)(4) item 828-4 2 units have on and off valve broken.

Event Description

Reference order (b)(4).Item 828-4, 2 units have on and off valve broken.

Manufacturer Narrative

Manufacturer report # 1531186-2015-00352 was submitted to the fda on 01/16/2015 in error.This product is not a medical device, not a reportable event.

• Brand Name: DLX HND SHWR W/84 IN HOSE AND WALL BRKT 1616700267
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 4429268
• MDR Text Key: 5169571
• Report Number: 1531186-2015-00352
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 01/16/2015,01/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 828-4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/16/2015
• Distributor Facility Aware Date: 01/07/2015
• Date Report to Manufacturer: 01/16/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other