MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,06,07 report with the FDA on 2011-10-27 for 3M STERI-GAS EO GAS CARTRIDGE 4-100 manufactured by 3m Health Care.
[2336905]
3m received info from a customer with apl (acute promyelocytic leukemia), an employee for a facility where he had past occupational exposure to high levels of ethylene oxide (eo), attributes his disease to general facility exposure to eo and lack of follow-up/inadequate records of sampling at the facility. The employee explained to 3m occupational health that he does not believe the 3m steri-gas equipment is a problem and understands the 3m device meets all cartridges are a problem. He filed worker's compensation (wc) claim in the federal system and has been denied at present (fed. Wc agreed he was able to show that he had been exposed to eo above the legal limits and agreed he was able to show that he was diagnosed with apl, but did not show connection/link between eo exposure and apl).
Patient Sequence No: 1, Text Type: D, B5
[9426019]
No other adverse pt effects were reported. If additional info is received, a f/u report will be submitted. Definition of eval: conclusion - no eval will be performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2011-00107 |
| MDR Report Key | 2316680 |
| Report Source | 04,06,07 |
| Date Received | 2011-10-27 |
| Date of Report | 2011-09-26 |
| Date of Event | 2011-09-26 |
| Date Mfgr Received | 2011-09-26 |
| Date Added to Maude | 2011-11-03 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANDREA GRABANSKI |
| Manufacturer Street | 3M CENTER, BLDG. 275-5W-06 |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517331047 |
| Manufacturer G1 | BALCHEM |
| Manufacturer Street | 95 BALCHEM LANE |
| Manufacturer City | GREEN POND SC 29446544 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 29446 5443 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M STERI-GAS EO GAS CARTRIDGE |
| Generic Name | 880.6860 STERILIZER, ETHYLENE-OXIDE GAS |
| Product Code | FLI |
| Date Received | 2011-10-27 |
| Model Number | NA |
| Catalog Number | 4-100 |
| Lot Number | NK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | ST. PAUL MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2011-10-27 |