MAUDE Adverse Event Report: INVAMEX FOLDING SHOWER CHAIR W/BACK 9153634972; ADAPTOR, HYGIENE

Model Number 9981

Device Problem Collapse (1099)

Patient Problems Contusion (1787); Fall (1848); Pain (1994)

Event Date 11/04/2015

Event Type  malfunction  

Manufacturer Narrative

Should additional information become available a supplemental record will be filed.User¿s manual review (1145752 rev.C, page 1) - ensure that the snap buttons fully protrude through their respective adjustment holes.Always observe the weight limit on the labeling of your product.Check that all labels are present and legible.Replace if necessary.

Event Description

The end users daughter states the shower chair collapsed while in use.She states her mother fell to the floor of the tub and is complaining of pain in her back and has a swollen large contusion on her back.She states her mother has a doctors appointment and the doctor advised her mother rest until the appointment.The end user's daughter states the legs don't snap into place and when her mother sat down, the unit collapsed.The end user weighs (b)(6) and has limited mobility but is over the weight cap which is 250 pounds.Update from 11/12/2015: end user's daughter stated her mom still hasn't gone to the doctor.For now she is very sore and bruised and has home health nurses helping her bathe and assisting her.No other medical intervention at this time.End user is requesting a transfer bench so she can get in the tub easier.Confirmed size will fit in tub and weight cap is 400 on the transfer bench.No further information provided.

• Brand Name: FOLDING SHOWER CHAIR W/BACK 9153634972
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): INVAMEX; parque industrial manimex; reynosa 88780 ; MX 88780
• Manufacturer (Section G): INVAMEX; parque industrial manimex; reynosa 88780 ; MX 88780
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5254874
• MDR Text Key: 32465377
• Report Number: 9616091-2015-02737
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9981
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/05/2015
• 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 Weight: 119