FDA Adverse Event
Other
Summary report: N
INCA
MDR report key: 4340656
·
Received December 9, 2014
Report
- Report Number
- 1216677-2014-00021
- Event Type
- Other
- Date Received
- December 9, 2014
- Date of Event
- November 21, 2014
- Report Date
- November 21, 2014
- Manufacturer
- COOPERSURGICAL, INC.
- Product Code
- BZD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). COOPERSURGICAL INC IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. A FINAL REPORT WILL BE FILED AFTER CUSTOMER FOLLOW UP AND INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
HOSPITAL REPORTED "ADAPTOR CAME LOOSE RIGHT AFTER APPLYING IT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 792715 | INCA | BZD | COOPERSURGICAL, INC. | 44-2715 | 159915 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |