MAUDE Adverse Event Report: MEDLINE MEDLINE PADDED TUB BENCH

Lot Number J061255396

Device Problem Scratched Material (3020)

Patient Problem Abrasion (1689)

Event Date 03/17/2016

Event Type  malfunction  

Event Description

Patient sustained 4 small abrasions on posterior right leg behind his knee from using the medline padded tub bench lot #j061255396.The lower lip/base of the padded seat where the seams fused together was very sharp and extended about 2/10" from the smooth sides.The seam projection was identified running the length of all of the lower edges of the padded seat.

• Brand Name: MEDLINE PADDED TUB BENCH
• Type of Device: TUB BENCH
• Manufacturer (Section D): MEDLINE
• MDR Report Key: 5535518
• MDR Text Key: 41532143
• Report Number: MW5061333
• Device Sequence Number: 1
• Product Code: ILS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: J061255396
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 94