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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX, SA IMIPENEM IP 32 WW S30

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BIOMERIEUX, SA IMIPENEM IP 32 WW S30 Back to Search Results
Catalog Number 412374
Device Problem Low Test Results (2458)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
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Brand NameIMIPENEM IP 32 WW S30
Type of DeviceIMIPENEM IP 32 WW S30
Manufacturer (Section D)
BIOMERIEUX, SA
3 route de port michaud
la balme 38390
FR 38390
Manufacturer (Section G)
BIOMERIEUX, SA
3 route de port michaud
la balme 38390
FR 38390
Manufacturer Contact
matthew locus
595 anglum road
hazelwood, MO 63042
MDR Report Key15251401
Report Number9615754-2022-00098
Device Sequence Number1
Product Code JWY
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K960989
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Literature,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number412374
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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