FDA Adverse Event
Injury
Summary report: N
GCY
MDR report key: 869140
·
Received June 13, 2007
Report
- Report Number
- 1018233-2007-00034
- Event Type
- Injury
- Date Received
- June 13, 2007
- Product Code
- GCY
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
NO SAMPLE OR LOT NUMBER INFO WERE PROVIDED FOR INVESTIGATION. THE BRAND NAME PROVIDED IS A COMPETITOR'S BRAND NAME FOR WHICH THIS MFR DOES HAVE A SIMILAR PRODUCT. THE EXACT DEVICE BRAND NAME, PRODUCT NUMBER AND LOT NUMBER WERE NOT PROVIDED AND REMAIN UNK. ADD'L INFO HAS BEEN REQUESTED, BUT HAS NOT BEEN RECEIVED. BASELINE REPORT HAS BEEN FILED FOR THIS MFR'S WOUND DRAINS. CORRECTIVE/ADDITIONS TO THE USER FACILITY REPORT HAS BEEN MADE ON THIS FORM IN PRINT WITH BLUE INK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GCY | GCY | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |