FDA Adverse Event
Malfunction
Summary report: N
2-0 DEXON 30" GREEN CE6
MDR report key: 223785
·
Received May 13, 1999
Report
- Report Number
- 2648188-1999-00007
- Event Type
- Malfunction
- Date Received
- May 13, 1999
- Report Date
- April 14, 1999
- Manufacturer
- KENDALL HEALTHCARE PRODUCTS CO.
- Product Code
- GAN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE DEVICE WAS USED DURING A SPAY AND NEUTER PROCEDURE. REPORTEDLY, THE ANIMAL HAD AN ALLERGIC REACTION. THE DR HAS REPORTED NO INJURY OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2-0 DEXON 30" GREEN CE6 Implant | ABSORBABLE SURGICAL SUTURE | GAN | KENDALL HEALTHCARE PRODUCTS CO. | NA | 961241 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |