MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-02-29 for 3M STERI-VAC(TM) GAS STERILIZER/AERATOR 4XL manufactured by 3m Health Care.
[39261865]
The report indicated female in their 30's. Specific information on the serial number was not provided within the system report. Without this information it is no possible to provide a manufacturer date. In follow-up with the service department there was a strong indication the sterilizer was functioning and met specification. It appears the canister may not have been installed correctly into the sterilizer by the user therefore, resulting in its difficulty in removal and the remaining residual eo liquid. This report is concerning a co-worker who was in the area at the time. Report 2110898-2016-00026 was sent to the fda regarding the user who actually removed the canister from the sterilizer.
Patient Sequence No: 1, Text Type: N, H10
[39261866]
A female employee in her 30s was working near a 3m steri-vac (tm) gas sterilizer/aerator (model 4xl) on (b)(6) 2016. Error codes displayed on the sterilizer screen; the sterilizer was in aeration mode. A co-worker opened the door of the sterilizer and removed the canister of ethylene oxide from the sterilizer and tossed it on the floor. The ethylene oxide alarm sounded in the room. The woman alleged she may have felt a droplet of liquid on her cheek under her left eye when the co-worker removed the canister. She showered immediately and was taken by ambulance to the facility's occupational medical clinic. She showered again for 15 minutes and was evaluated by a physician. No marks were noted. The female employee was seen in the clinic the next day. A red mark was noted below her left eye. No medical treatment was specified. The red mark resolved within two days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2016-00027 |
| MDR Report Key | 5467332 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-02-29 |
| Date of Report | 2016-02-09 |
| Date of Event | 2016-02-05 |
| Date Mfgr Received | 2016-02-09 |
| Date Added to Maude | 2016-02-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LINDA JOHNSEN |
| Manufacturer Street | 3M CENTER, BUILDING 275-5W-06 2510 CONWAY AVE |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517374376 |
| Manufacturer G1 | 3M COMPANY |
| Manufacturer Street | 1617 NORTH FRONT ST. |
| Manufacturer City | NEW ULM MN 56073 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 56073 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M STERI-VAC(TM) GAS STERILIZER/AERATOR |
| Generic Name | STERILIZER EO GAS |
| Product Code | FLF |
| Date Received | 2016-02-29 |
| Model Number | 4XL |
| Operator | HOSPITAL SERVICE TECHNICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 2510 CONWAY AVE ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-29 |