Brand Name | HENRY SCHEIN |
Type of Device | CRITERION LATEX SURGICAL GLOVE |
Manufacturer (Section D) |
WRP ASIA PACIFIC SDN. BHD. |
lot 1, jalan 3 |
kawasan perusaahan bandar baru |
salak tinggi, selangor 43900 |
MY 43900 |
|
MDR Report Key | 17320506 |
MDR Text Key | 319098066 |
Report Number | 2411236-2023-00002 |
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 |
Distributor
|
Reporter Occupation |
Administrator/Supervisor
|
Type of Report
| Initial |
Report Date |
07/13/2023,06/19/2023 |
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 Catalogue Number | 570-2104 |
Device Lot Number | W102690365 |
Was Device Available for Evaluation? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 07/13/2023 |
Distributor Facility Aware Date | 06/19/2023 |
Event Location |
Other
|
Date Report to Manufacturer | 07/12/2023 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 07/13/2023 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 28 YR |
Patient Sex | Female |
|
|