MESA LABORATORIES PH 7.0 BUFFER SOLUTION PT PART # 02.0031

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-01-24 for MESA LABORATORIES PH 7.0 BUFFER SOLUTION PT PART # 02.0031 manufactured by Mesa Laboratories.

Event Text Entries

[4067261] We have learned of a potential mold contamination of (b)(4)laboratories 7. 0 ph buffer solution that is used at this facility. At this time, we are not aware of any adverse events associated with this problem; however, we want to alert both (b)(4) laboratories and the fda of this issue.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3608813
MDR Report Key3608813
Date Received2014-01-24
Date of Report2013-10-08
Date of Event2013-10-04
Date Added to Maude2014-02-07
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameMESA LABORATORIES PH 7.0 BUFFER SOLUTION PT
Generic NameMESA LABORATORIES PH 7.0 BUFFER SOLUTION PT
Product CodeJCC
Date Received2014-01-24
Catalog NumberPART # 02.0031
Lot NumberML-P7-1105
Device Expiration Date2014-06-04
Device Sequence No1
Device Event Key0
ManufacturerMESA LABORATORIES

Device Sequence Number: 2

Brand NameMESA LABORATORIES PH 7.0 BUFFER SOLUTION QRT BTL
Generic NameMESA LABORATORIES PH 7.0 BUFFER SOLUTION QRT BTL
Product CodeJCC
Date Received2014-01-24
Catalog NumberPART # 02.0030
Lot NumberML-P7-1118
Device Expiration Date2014-06-04
Device Sequence No2
Device Event Key0
ManufacturerMESA LABORATORIES


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2014-01-24

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