FDA Adverse Event
Injury
Summary report: N
6833 UMBILICAL CORD CLAMP, 100/CS
MDR report key: 280311
·
Received May 31, 2000
Report
- Report Number
- 1046367-2000-00020
- Event Type
- Injury
- Date Received
- May 31, 2000
- Date of Event
- May 2, 2000
- Report Date
- May 31, 2000
- Manufacturer
- DEROYAL
- Product Code
- HFW
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
BABY LOSING BLOOD THROUGH THE CORD CLAMP. THIS OCCURRED AFTER CORD CLIPPING PROCEDURE. BABY REQUIRED NO ADDITIONAL TREATMENT. BLOOD LOSS AT A MINIMUM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6833 UMBILICAL CORD CLAMP, 100/CS | 7N8 UMBILICAL CORD CLAMP | HFW | DEROYAL | 07 | 194854 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 0 DAY | Life Threatening |