Brand Name | TROJAN BARESKIN CONDOMS |
Type of Device | CONDOM |
Manufacturer (Section D) |
CHURCH & DWIGHT CO., INC. |
500 charles ewing boulevard |
ewing NJ 08628 |
|
Manufacturer (Section G) |
OKAMOTO INDUSTRIES, INC. |
no. 1, nishiyama-itabashi-cho |
|
ryugasaki-shi, ibaraki-prefecture 301-0 801 |
JA
301-0801
|
|
Manufacturer Contact |
stacey
harshaw
|
469 north harrison street |
princeton, NJ 08543
|
6098067868
|
|
MDR Report Key | 10722165 |
MDR Text Key | 214119860 |
Report Number | 2280705-2020-00027 |
Device Sequence Number | 1 |
Product Code |
HIS
|
UDI-Device Identifier | 00022600998532 |
UDI-Public | 00022600998532 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K090259 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
10/22/2020 |
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 Model Number | 2260099853 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
10/13/2020 |
Initial Date FDA Received | 10/22/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|