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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. STERILIZER Back to Search Results
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
The user facility reported via user facility medsun report the following, "sterile processing department sterilizer had a wet load of surgical kits. All items in load were recalled and reprocessed. Sterilizer taken out of service and repair tech called to evaluate. ".
 
Manufacturer Narrative
Steris became aware of this event on october 22, 2021 through our periodic review of the medsun database. The report did not identify the name or location of the user facility of the device in question. To date we have not been informed of this event directly from the user facility. Should we obtain additional information regarding the user facility or specific sterilizer subject of this event, a follow-up report would be filed with the results of our investigation.
 
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Type of DeviceSTERILIZER
Manufacturer (Section D)
STERIS MEXICO, S. DE R.L. DE C.V.
avenida avante 790
parque industrial guadalupe
guadalupe, 67190
MX 67190
MDR Report Key12683891
MDR Text Key282495702
Report Number3005899764-2021-00055
Device Sequence Number1
Product Code FLE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial
Report Date 10/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/22/2021
Is This a Reprocessed and Reused Single-Use Device? No

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