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

Model Number 96-2

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problems Gangrene (1873); Vomiting (2144); Chills (2191)

Event Date 07/08/2016

Event Type  Injury  

Event Description

Consumer states that when her husband was taking a shower, the right rear leg gave out inwards causing the patient to fall in the shower and the back cracked as well.Injuries, he has back pain and he had a sore on his sacral area that is now irritated and his head is sore from hitting it on the back of the shower.No medical attention at this time has been sought.Update from customer service on 07/29/2016: the end user's wife called today to make us aware her husband was admitted into the hospital on (b)(6) 2016 for high fevers due to infection and the end user was given a cat scan to seek the area for the infection and the findings showed the infection was causing him to have chills, vomiting.The end user's wife stated the area of infection was the heel of the right foot had gas gangrene which required emergency surgery and had to go into hyperbaric oxygen chamber to help treat the gas gangrene and alleges this was due to the fall in the shower form using the shower chair.The end user's wife alleges he has since had two additional surgeries due to more infection that was found in the end user's body, the right foot ankle and heel.Return material authorization has been issued for the return of this device for investigation; return not yet received.Investigation to be completed when the device is returned.Should additional information become available, a supplemental record will be filed.

• Brand Name: CAREGUARD TOOL LESS SHOWER CHAIR WITH BACK 2/CARTON 9153645725
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): PINGHU WEIFENG MATERIAL TECHNOLOGY; pinghu ; CH
• MDR Report Key: 5850567
• MDR Text Key: 51269583
• Report Number: 1531186-2016-00019
• 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: Distributor
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 08/01/2016,07/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 96-2
• 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: 08/01/2016
• Distributor Facility Aware Date: 07/29/2016
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 08/01/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 113