FDA Adverse Event
Other
Summary report: N
TRIMO SAN
MDR report key: 4938245
·
Received July 22, 2015
Report
- Report Number
- 1216677-2015-00051
- Event Type
- Other
- Date Received
- July 22, 2015
- Date of Event
- July 1, 2015
- Report Date
- July 2, 2015
- Manufacturer
- COOPERSURGICAL, INC.
- Product Code
- KMJ
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. THE DEVICE INVOLVED IN THE COMPLAINT HAS NOT BEEN RETURNED BY THE CUSTOMER FOR EVALUATION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE FILED. REFERENCE E-COMPLAINT NUMBER: (B)(4).
Description of Event or Problem · 1
CONSUMER DIAGNOSED WITH URINARY TRACT INFECTION. REFERENCE E-COMPLAINT NUMBER: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 475489 | TRIMO SAN | TRIMO SAN | KMJ | COOPERSURGICAL, INC. | MX5030 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |