Brand Name | TROJAN FIRE & ICE CONDOMS UNSPECIFIED |
Type of Device | LATEX CONDOM |
Manufacturer (Section D) |
CHURCH & DWIGHT CO., INC. |
500 charles ewing blvd. |
ewing NJ 08628 |
|
Manufacturer (Section G) |
CHURCH & DWIGHT CO., INC. |
1851 touchstone drive |
|
south chesterfield VA 23834 |
|
Manufacturer Contact |
stacey
harshaw
|
469 north harrison st. |
princeton, NJ 08543
|
6098067868
|
|
MDR Report Key | 9349742 |
MDR Text Key | 197318692 |
Report Number | 2280705-2019-00031 |
Device Sequence Number | 1 |
Product Code |
HIS
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K120287 |
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 |
11/20/2019 |
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
|
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
11/08/2019 |
Initial Date FDA Received | 11/20/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|