ASEPTIC TRANSFER KIT HOUSING 89-8510-440-10

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-10-28 for ASEPTIC TRANSFER KIT HOUSING 89-8510-440-10 manufactured by Zimmer Surgical Sa.

MAUDE Entry Details

• Report Number: 0008031000-2019-00020
• MDR Report Key: 9245301
• Report Source: FOREIGN,HEALTH PROFESSIONAL
• Date Received: 2019-10-28
• Date of Report: 2020-01-24
• Date of Event: 2019-10-02
• Date Mfgr Received: 2020-01-20
• Device Manufacturer Date: 2019-02-27
• Date Added to Maude: 2019-10-28
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. CHRISTINA ARNT
• Manufacturer Street: 56 E. BELL DRIVE
• Manufacturer City: WARSAW IN 46582
• Manufacturer Country: US
• Manufacturer Postal: 46582
• Manufacturer Phone: 5745273773
• Manufacturer G1: ZIMMER SURGICAL SA
• Manufacturer Street: 3, CH. DU PRE FLEURI PLAN-LES-OUATES
• Manufacturer City: GENEVA 1228
• Manufacturer Country: SZ
• Manufacturer Postal Code: 1228
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ASEPTIC TRANSFER KIT HOUSING
• Generic Name: ASEPTIC TRANSFER KIT HOUSING
• Product Code: MOQ
• Date Received: 2019-10-28
• Model Number: NA
• Catalog Number: 89-8510-440-10
• Lot Number: 5012130
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ZIMMER SURGICAL SA
• Manufacturer Address: 3, CH. DU PRE FLEURI PLAN-LES-OUATES GENEVA 1228 SZ 1228

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-10-28