TSA W/LEC, PS80 111101

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-22 for TSA W/LEC, PS80 111101 manufactured by Thermo Fisher Scientific.

Event Text Entries

[75974528] Upon opening box of contact plates, technician discovered contaminated remel tsa w/lec, ps80 contact plate with growth (ref: 111101, lot # 139212, exp. 08/03/2017). A second contaminated plate with same lot # discovered during call with remel technical services.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5069998
• MDR Report Key: 6587330
• Date Received: 2017-05-22
• Date of Report: 2017-05-22
• Date of Event: 2017-05-22
• Date Added to Maude: 2017-05-24
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PHARMACIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: TSA W/LEC, PS80
• Generic Name: TSA W/LEC, PS80
• Product Code: LIB
• Date Received: 2017-05-22
• Catalog Number: 111101
• Lot Number: 139212
• Device Expiration Date: 2017-08-03
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: THERMO FISHER SCIENTIFIC
• Manufacturer Address: WALTHAM MA 02451 US 02451

Device Sequence Number: 2

• Brand Name: TSA W/LEC, PS80
• Generic Name: TSA W/LEC, PS80
• Product Code: LIB
• Date Received: 2017-05-22
• Catalog Number: 111101
• Lot Number: 139212
• Device Expiration Date: 2017-08-03
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: THERMO FISHER SCIENTIFIC
• Manufacturer Address: WALKTHAM MA 02451 US 02451

Patients

Patient Number	Treatment	Outcome	Date
1	0		2017-05-22