MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2000-01-12 for STERI-VAC 4XL NA manufactured by 3m.
[146905]
A health care worker opened the door of the sterilizer and had a hard time getting the cartridge out. Worker saw liquid in the sterilizer and some liquid spilled on her.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2000-00002 |
| MDR Report Key | 259944 |
| Report Source | 05,07 |
| Date Received | 2000-01-12 |
| Date of Report | 2000-01-12 |
| Date of Event | 1999-12-06 |
| Date Mfgr Received | 1999-12-07 |
| Device Manufacturer Date | 1999-04-01 |
| Date Added to Maude | 2000-01-28 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | GAIL STEWARD |
| Manufacturer Street | 3M CENTER BLDG. 275-3E-08 PO BOX 33275 |
| Manufacturer City | ST. PAUL MN 551333275 |
| Manufacturer Country | US |
| Manufacturer Postal | 551333275 |
| Manufacturer Phone | 6127369057 |
| Manufacturer G1 | 3M |
| Manufacturer Street | 1617 N. FRONT ST. P.O. BOX 95 |
| Manufacturer City | NEW ULM MN 56073009 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 56073 0095 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERI-VAC 4XL |
| Generic Name | GAS STERILIZER |
| Product Code | FLF |
| Date Received | 2000-01-12 |
| Model Number | 4XL |
| Catalog Number | NA |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 251743 |
| Manufacturer | 3M |
| Manufacturer Address | 3M CENTER, BLDG. 275-3E-08 P.O. BOX 33275 ST. PAUL MN 551333275 US |
| Baseline Brand Name | STERI-VAC |
| Baseline Generic Name | ETHYLENE OXIDE GAS STERILIZER |
| Baseline Model No | 4XL |
| Baseline Catalog No | 4XL |
| Baseline ID | NA |
| Baseline Device Family | STERI-VAC |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K812867 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-01-12 |