• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

E. M. ADAMS CO., INC. SOFT RESTRAINT RESTRAINT, PROTECTIVE Back to Search Results
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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSOFT RESTRAINT
Type of DeviceRESTRAINT, PROTECTIVE
Manufacturer (Section D)
E. M. ADAMS CO., INC.
MDR Report Key12507023
MDR Text Key272774019
Report NumberMW5104105
Device Sequence Number1
Product Code FMQ
Number of Events Reported1
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 Received09/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberHN07-21; 70806
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 09/20/2021 Patient Sequence Number: 1
-
-