Brand Name | SMITH AND NEPHEW RICHARDS OFFSET SHELL |
Type of Device | IMPACTOR |
Manufacturer (Section D) |
|
MDR Report Key | 8208375 |
MDR Text Key | 131997310 |
Report Number | MW5082713 |
Device Sequence Number | 1 |
Product Code |
HWA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
12/17/2018 |
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 Operator |
Health Professional
|
Device Model Number | 71368569 |
Device Lot Number | 14JM05832 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/14/2018 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 12/31/2018 |
Was Device Evaluated by Manufacturer? |
No Information
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|