MAUDE Adverse Event Report: UNKNOWN CONTOURED TRANSFER BENCH 9153631802; ADAPTOR, HYGIENE

Model Number 9670U

Device Problems Defective Component (2292); Material Deformation (2976)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Arm received has no holes drilled and the bottom tube not flattened can not attach to side.

Manufacturer Narrative

Should additional information become available, a supplemental record will be file.

• Brand Name: CONTOURED TRANSFER BENCH 9153631802
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4818269
• MDR Text Key: 5916882
• Report Number: 1525712-2015-03229
• 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: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9670U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other