MAUDE Adverse Event Report: E.M. ADAMS CO., INC. E.M Adams co, inc.; Restraint, Protective

Model Number	70806-1
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
At a minimum of three times in the last two weeks, icu staff has attempted to use the "e.M adams company limb holder" on intubated patients, and the clip that is on the end of the restraint that attaches to the bed fails, allowing the patient to have free movement with their limbs, potentially allowing the patient to self extubate.When looking at a working clip and the clip that does not work properly, there is a sort of tab that i can see is in a different spot, which i suspect is the reason for the clip not working.

• Brand Name: E.M Adams co, inc.
• Common Device Name: Restraint, Protective
• Manufacturer (Section D): E.M. ADAMS CO., INC.; 7496 commercial circle; fort pierce FL 34951
• MDR Report Key: 50549160
• Report Number: 50549160
• Device Sequence Number: 16042888
• Product Code: FMQ
• UDI-Device Identifier: 10840200305393
• UDI-Public: (01)10840200305393
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2026
• Report Date (Section F): 08/04/2026

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 Model Number: 70806-1
• Device Catalogue Number: 70806
• Device Lot Number: NH 05-26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/19/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/01/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/04/2026