FDA Adverse Event
Malfunction
Summary report: N
STERRAD 100S STERILIZER
MDR report key: 1060771
·
Received June 12, 2008
Report
- Report Number
- 2084725-2008-00274
- Event Type
- Malfunction
- Date Received
- June 12, 2008
- Date of Event
- May 22, 2008
- Report Date
- May 22, 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
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE FSE ASSESSED THE UNIT AND FOUND IT OPERATING TO MANUFACTURER SPECS.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT ONE OF THE HEALTHCARE WORKERS EXPERIENCED "BURN" WITHOUT PAIN ON THEIR PALM. THE BURNED AREA WAS REPORTED TO BE DISCOLORED ("SLIGHTLY WHITE"). IT WAS REPORTED THAT THE INCIDENT OCCURRED WHILE THE HEALTHCARE WORKER WAS UNLOADING THE PROCESSED DEVICES. ONE OF THE DEVICES HAD DROPLETS AND THE HEALTHCARE WORKER FELT PAIN WHEN HE/SHE TOUCHED THE DROPLETS. THE HEALTHCARE WORKER DID NOT SEEK MEDICAL ATTENTION AND TREATMENT. THE SERVICE ENGINEER WENT TO THE FACILITY TO ASSESS THE UNIT.
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 |