FDA Adverse Event
Other
Summary report: N
CANNULA CURETTE 8MM LONG
MDR report key: 3705618
·
Received March 18, 2014
Report
- Report Number
- 1216677-2014-00004
- Event Type
- Other
- Date Received
- March 18, 2014
- Date of Event
- February 20, 2014
- Report Date
- March 14, 2014
- Manufacturer
- COOPERSURGICAL, INC.
- Product Code
- HFC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
COOPERSURGICAL INC IS CURRENTLY INVESTIGATING THE STATED COMPLAINT. THE DEVICE INVOLVED IN THE COMPLAINT HAS NOT BEEN RETUNED BY THE CUSTOMER FOR EVALUATION. ONCE ALL INFORMATION IS RECEIVED FROM THE CUSTOMER AND THE INVESTIGATION HAS BEEN COMPLETED A FOLLOW-UP REPORT WILL BE FILED. (B)(4).
Description of Event or Problem · 1
HOSPITAL REPORTED EXCESSIVE BLEEDING OCCURRED DURING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 161852 | CANNULA CURETTE 8MM LONG | CANNULA CURETTE | HFC | COOPERSURGICAL, INC. | MX508 | 144853 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |