Brand Name | E.M ADAMS CO, INC. |
Type of Device | RESTRAINT, PROTECTIVE |
Manufacturer (Section D) |
E.M. ADAMS, INC. |
7496 commercial circle, |
ft pierce FL 34951 |
|
MDR Report Key | 10655205 |
MDR Text Key | 210604768 |
Report Number | 10655205 |
Device Sequence Number | 1 |
Product Code |
FMQ
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
10/07/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Model Number | 70806-1 |
Device Lot Number | 07-20 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 10/07/2020 |
Device Age | 1 YR |
Event Location |
Hospital
|
Date Report to Manufacturer | 10/09/2020 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 10/09/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Death;
|
Patient Age | 18615 DA |
Patient Weight | 113 |
|
|