MICK 200, TP APPL, 20CM LONG, INSTRUMENT 8810-I-200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-21 for MICK 200, TP APPL, 20CM LONG, INSTRUMENT 8810-I-200 manufactured by Eckert & Ziegler Bebig / Mick Radio-nuclear Instrument, Inc..

Event Text Entries

[180851008] Mick 200 applicator malfunction x4 - serial # (b)(4) - each mick experienced a mechanical malfunction - two clip failures (determined to be from not lubricating pivot mechanism) and two seed jamming's - may be related to not performing sterile water lubrication during procedure. Less than the intended number of seeds were placed as a result. Reviewed seed placement and determined that adequate placement and dosing achieved. No further surgical intervention indicated. Pt will be followed with radiological studies and with psa labs as previously planned. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5093218
• MDR Report Key: 9744852
• Date Received: 2020-02-21
• Date of Report: 2020-02-19
• Date of Event: 2019-12-11
• Date Added to Maude: 2020-02-24
• 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: RISK MANAGER
• 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: 3

Device Sequence Number: 1

• Brand Name: MICK 200, TP APPL, 20CM LONG, INSTRUMENT
• Generic Name: SYSTEM, APPLICATOR, RADIONUCLIDE, MANUAL
• Product Code: IWJ
• Date Received: 2020-02-21
• Model Number: 8810-I-200
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ECKERT & ZIEGLER BEBIG / MICK RADIO-NUCLEAR INSTRUMENT, INC.
• Manufacturer Address: MT. VERNON NY 10550 US 10550

Device Sequence Number: 2

• Brand Name: MICK 200, TP APPL, 20CM LONG, INSTRUMENT
• Generic Name: SYSTEM, APPLICATOR, RADIONUCLIDE, MANUAL
• Product Code: IWJ
• Date Received: 2020-02-21
• Model Number: 8810-I-200
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: ECKERT & ZIEGLER BEBIG / MICK RADIO-NUCLEAR INSTRUMENT, INC.

Device Sequence Number: 3

• Brand Name: MICK 200, TP APPL, 20CM LONG, INSTRUMENT
• Generic Name: SYSTEM, APPLICATOR, RADIONUCLIDE, MANUAL
• Product Code: IWJ
• Date Received: 2020-02-21
• Model Number: 8810-I-200
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: ECKERT & ZIEGLER BEBIG / MICK RADIO-NUCLEAR INSTRUMENT, INC.

Device Sequence Number: 4

• Brand Name: MICK 200, TP APPL, 20CM LONG, INSTRUMENT
• Generic Name: SYSTEM, APPLICATOR, RADIONUCLIDE, MANUAL
• Product Code: IWJ
• Date Received: 2020-02-21
• Model Number: 8810-I-200
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: ECKERT & ZIEGLER BEBIG / MICK RADIO-NUCLEAR INSTRUMENT, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-02-21