MAUDE Adverse Event Report: E. M. ADAMS CO., INC. SOFT RESTRAINT; RESTRAINT, PROTECTIVE

Lot Number HN07-21; 70806

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/12/2021

Event Type  Injury  

Event Description

Soft wrist restraint strap tore when resistance placed on strap.Fda safety report id# (b)(4).

• Brand Name: SOFT RESTRAINT
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): E. M. ADAMS CO., INC.
• MDR Report Key: 12507023
• MDR Text Key: 272774019
• Report Number: MW5104105
• 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: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: HN07-21; 70806
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR