MAUDE Adverse Event Report: PROFEX / PROFESSIONAL SPECIALTIES CO., INC. BLACK SAFETY STRAP PRODUCT # 345-90; RESTRAINT, PROTECTIVE

Lot Number 508151

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 08/25/2021

Event Type  Injury  

Event Description

Safety strap broke while on patient as he arched up his back while on operating room table.Fda safety report id# (b)(4).

• Brand Name: BLACK SAFETY STRAP PRODUCT # 345-90
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): PROFEX / PROFESSIONAL SPECIALTIES CO., INC.
• MDR Report Key: 12452738
• MDR Text Key: 271045089
• Report Number: MW5103824
• Device Sequence Number: 1
• Product Code: FMQ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 09/07/2021

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: Health Professional
• Device Lot Number: 508151
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR