MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-01-04 for 3M(TM) STERI-VAC (TM) 8XL STERILIZER/AERATOR manufactured by 3m Health Care.
[132204090]
Device is under investigation. Initial analysis by service engineers indicates over-temperature condition. Components have been requested for additional analysis and root cause determination. The sterilizer was manufactured in year 2005. This mdr represents patient 1; emdr 2110898-2019-00003 represents patient 2. End of report.
Patient Sequence No: 1, Text Type: N, H10
[132204091]
A (b)(6) female employee alleged that she experienced perioral itching and an intense headache after a 3m? Steri-vac? 8xl sterilizer/aerator (serial number (b)(4)) chamber was opened and a 3m? Steri-gas ethylene oxide cartridge was found to be broken. The users at the hospital reported that the sterilized material and the inside of the chamber were very hot. The patient saw a nurse for the symptoms and no treatment was provided. The symptoms subsided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2019-00002 |
| MDR Report Key | 8219436 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-01-04 |
| Date of Report | 2019-03-28 |
| Date of Event | 2018-12-06 |
| Date Mfgr Received | 2018-12-06 |
| Date Added to Maude | 2019-01-04 |
| 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. DIANNE GIBBS |
| 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 | 6517379117 |
| 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(TM) STERI-VAC (TM) 8XL STERILIZER/AERATOR |
| Generic Name | STERILIZER EO GAS |
| Product Code | FLF |
| Date Received | 2019-01-04 |
| Returned To Mfg | 2019-02-07 |
| Model Number | 8XL |
| Catalog Number | 8XL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2019-01-04 |