FDA Adverse Event
Malfunction
Summary report: N
STERRAD 100S STERILIZER
MDR report key: 1171520
·
Received September 17, 2008
Report
- Report Number
- 2084725-2008-00586
- Event Type
- Malfunction
- Date Received
- September 17, 2008
- Date of Event
- August 27, 2008
- Report Date
- August 27, 2008
- Manufacturer
- ADVANCED STERILIZATION PRODUCTS
- Product Code
- MLR
- PMA / PMN Number
- K991999
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT AN EMPLOYEE EXPERIENCED HUMAN REACTION WHEN CHANGING THE VAPORIZER PLATE AND BOWL. THE EMPLOYEE TOUCHED THE RESIDUE REMAINING ON THE BOWL. THE EMPLOYEE'S RIGHT HAND FINGER TIPS TURNED WHITE AND ITCHED. THE EMPLOYEE HANDLED THE VAPORIZER PLATE WITHOUT GLOVES. THE CUSTOMER DID NOT RESPOND TO ASP'S ATTEMPT IN RETRIEVING MORE INFO REGARDING PATIENT OUTCOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STERRAD 100S STERILIZER | STERRAD EQUIPMENT (MLR) | MLR | ADVANCED STERILIZATION PRODUCTS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | STERRAD CASSETTE| EXPIRATION DATE:08/2009 |