FDA Adverse Event
Malfunction
Summary report: N
STERRAD 100S STERILIZATION SYSTEM
MDR report key: 1052324
·
Received May 22, 2008
Report
- Report Number
- 2084725-2008-00204
- Event Type
- Malfunction
- Date Received
- May 22, 2008
- Date of Event
- April 24, 2008
- Report Date
- April 24, 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
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
CAPITAL EQUIPMENT, THE FSE WENT TO THE FACILITY. THE FSE FOUND THAT THERE WAS NOT A VAPORIZER PLATE IN THE UNIT.
Description of Event or Problem · 1
THE CUSTOMER REPORTED AN EMPLOYEE WHO EXPERIENCED HYDROGEN PEROXIDE CONTACT. THE EMPLOYEE COMPLAINED OF WHITE SKIN DISCOLORATION AND DISCOMFORT. THE EMPLOYEE RINSED THE CONTACT AREA WITH RUNNING WATER FOR 15 MINUTES, THEY DID NOT SEE A DOCTOR OR REQUIRE TREATMENT. THE ASP FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY TO ASSESS THE UNIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STERRAD 100S STERILIZATION SYSTEM | STERILIZER | MLR | ADVANCED STERILIZATION PRODUCTS | 10101 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |