Brand Name | L.UNK |
Type of Device | CONDOM |
Manufacturer (Section D) |
NULATEX SDN. BHD. |
kluang johor,, 86000 |
MY 86000 |
|
MDR Report Key | 10264177 |
MDR Text Key | 198525304 |
Report Number | 1216894-2020-00001 |
Device Sequence Number | 1 |
Product Code |
HIS
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/07/2019 |
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 |
Lay User/Patient
|
Device Lot Number | NOT AVAILABLE |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 04/07/2019 |
Event Location |
Home
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 07/13/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|