Brand Name | NEEDLE COUNTER |
Type of Device | NEEDLE, SUTURING, DISPOSABLE |
Manufacturer (Section D) |
CARDINAL HEALTH 200, LLC |
waukegan IL 60085 |
|
MDR Report Key | 8678928 |
MDR Text Key | 147450374 |
Report Number | MW5087181 |
Device Sequence Number | 1 |
Product Code |
GAB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
06/04/2019 |
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 Expiration Date | 10/01/2020 |
Device Catalogue Number | SNE73SPVLI |
Device Lot Number | 219889 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 06/06/2019 |
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 Age | 43 YR |
Patient Weight | 71 |
|
|