MAUDE Adverse Event Report: INVAMEX SHOWER CHAIR PADDED VINYL 9153633401; ADAPTOR, HYGIENE

Model Number 9872

Device Problems Out-Of-Box Failure (2311); Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The dealer stated the back vinyl was torn upon his receipt.They stated they opened the box to find the back torn, there was no apparent damage to the box.

• Brand Name: SHOWER CHAIR PADDED VINYL 9153633401
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): INVAMEX; parque industrial manimex; reynosa 8878 0; MX 88780
• Manufacturer (Section G): INVAMEX; parque industrial manimex; reynosa 8878 0; MX 88780
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4622434
• MDR Text Key: 5763406
• Report Number: 9616091-2015-00774
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9872
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2015
• 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