FDA Adverse Event
Other
Summary report: N
GYN DISPOSABLES, INC
MDR report key: 1066255
·
Received June 27, 2008
Report
- Report Number
- 3006365741-2008-00001
- Event Type
- Other
- Date Received
- June 27, 2008
- Date of Event
- May 6, 2008
- Report Date
- June 17, 2008
- Manufacturer
- GYN-DISPOSABLES, INC.
- Product Code
- HDT
- PMA / PMN Number
- K073162
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INCORRECT LABEL WAS DISCOVERED LESS THAN ONE MONTH AFTER MANUFACTURER; AFFECTED PRODUCT POSED NO SAFETY RISK AS IT WAS CORRECTLY STERILIZED. PRODUCT HAS BEEN RE-LABELED WITH ETO AS THE CORRECT METHOD OF STERILIZATION.
Description of Event or Problem · 1
PRODUCT POUCH LABEL INDICATED INCORRECT STERILIZATION METHOD AS GAMMA IRRADIATION; CORRECT STERILIZATION METHOD FOR PRODUCT IN QUESTION IS ETHYLENE OXIDE. PRODUCT WAS CORRECTLY STERILIZED BY ETO BUT THE LABEL WAS INCORRECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GYN DISPOSABLES, INC | IUD INSERTION KIT | HDT | GYN-DISPOSABLES, INC. | 60996755 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |