Brand Name | HANDPIECE |
Type of Device | HANDPIECE, AIR-POWERED, DENTAL |
Manufacturer (Section D) |
HENRY SCHEIN, INC. |
41 weaver rd. |
denver PA 17517 |
|
MDR Report Key | 14161929 |
MDR Text Key | 289766601 |
Report Number | MW5109186 |
Device Sequence Number | 1 |
Product Code |
EFB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
04/18/2022 |
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? |
No
|
Device Operator |
Health Professional
|
Device Model Number | SURGIPRO 45 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/12/2022 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 04/19/2022 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
Required Intervention;
|
Patient Age | 37 YR |
Patient Sex | Male |
|
|