Brand Name | PROTEXIS PI |
Type of Device | POWDERED LATEX SURGEON'S GLOVES |
Manufacturer (Section D) |
CARDINAL HEALTH |
785 fort mill hwy. |
fort mill SC 29707 |
|
MDR Report Key | 6568667 |
MDR Text Key | 75257671 |
Report Number | 6568667 |
Device Sequence Number | 1 |
Product Code |
KGO
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial,Followup |
Report Date |
04/11/2017,05/01/2017 |
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 |
No Information
|
Device Expiration Date | 10/31/2019 |
Device Model Number | 2D72PT75X |
Device Catalogue Number | 2D72PT75X |
Device Lot Number | TS16110146 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 04/11/2017 |
Event Location |
Hospital
|
Date Report to Manufacturer | 04/11/2017 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 05/16/2017 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 07/14/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 39 YR |
|
|