MAUDE Adverse Event Report: INVAMEX CAREGUARD TOOL LESS SHOWER CHAIR WITH BACK 2/CARTON 9153645725; ADAPTOR, HYGIENE

Model Number 98071

Device Problems Component Missing (2306); Out-Of-Box Failure (2311); Date/Time-Related Software Problem (2582)

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

Event Type  malfunction  

Event Description

The provider states the bolt that holds on the the leg extension came off.The provider stets the end user noticed the issue before usng the unit.Please reference order number (b)(4) with original purchase.No injuries noted and theprovider staets the unit wasn't wobbly.She also states the stickers were removed form the unit so there isn't a date code or lot number to reference (b)(4).

• Brand Name: CAREGUARD TOOL LESS SHOWER CHAIR WITH BACK 2/CARTON 9153645725
• 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 44036 ; 8003336900
• MDR Report Key: 4473271
• MDR Text Key: 22068618
• Report Number: 9616091-2015-00353
• Device Sequence Number: 1
• Product Code: ITJ
• 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: 01/23/2015

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 Operator: Lay User/Patient
• Device Model Number: 98071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/23/2015
• Initial Date FDA Received: 02/02/2015
• 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