MESA LABORATORIES 7.0 PH BUFFER SOLUTION, PINT 02.0030

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 7.0 PH BUFFER SOLUTION, PINT 02.0030 manufactured by Mesa Laboratories.

Event Text Entries

[4318352] Received notification of potential mold growth in identified mesa lot numbers. Facility stock was evaluated and affected lot numbers identified and removed from facility inventory. No known adverse event from this product has occurred at this time.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3651271
• MDR Report Key: 3651271
• Date Received: 2014-01-24
• Date of Report: 2013-10-09
• Date of Event: 2013-10-03
• Date Added to Maude: 2014-02-28
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• 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: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: MESA LABORATORIES 7.0 PH BUFFER SOLUTION, PINT
• Generic Name: MESA LABORATORIES 7.0 PH BUFFER SOLUTION, PINT
• Product Code: JCC
• Date Received: 2014-01-24
• Catalog Number: 02.0030
• Lot Number: ML-P7-1138
• Device Expiration Date: 2014-07-07
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MESA LABORATORIES

Device Sequence Number: 2

• Brand Name: MESA LABORATORIES 7.0 PH BUFFER SOLUTION, QUART
• Generic Name: MESA LABORATORIES 7.0 PH BUFFER SOLUTION, QUART
• Product Code: JCC
• Date Received: 2014-01-24
• Catalog Number: 02.0030
• Lot Number: ML-P7-1118
• Device Expiration Date: 2014-01-12
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: MESA LABORATORIES

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2014-01-24