MAUDE Adverse Event Report: UNKNOWN

Device Problem Device Slipped (1584)

Patient Problems Laceration(s) (1946); Suture Abrasion (2497)

Event Date 07/18/2018

Event Type  Injury  

Event Description

The end user fell in the shower.His feet got tangled on the rubber tips of the front of the shower seat as he was turning around and while he was turning around he noticed the tip came off the legs of the seat.He had a gash on his ankle and a gash on his big toe on his right leg.His wife took him to the er and he had to get 7 stitches.The device and manufacturer is unknown.

• Brand Name: UNKNOWN
• Type of Device: UNKNOWN
• MDR Report Key: 7860458
• MDR Text Key: 119692879
• Report Number: 3012316249-2018-00051
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/10/2018
• Distributor Facility Aware Date: 08/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other