MILLER-ABBOTT TUBE 205000XX SIZE UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 1997-01-21 for MILLER-ABBOTT TUBE 205000XX SIZE UNK manufactured by Willy Rusch Ag.

Event Text Entries

[19698425] During intubation, the tube at the port came apart or ruptured. Stated device was left in pt.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 48207-1997-00007
• MDR Report Key: 65287
• Report Source: 06,07
• Date Received: 1997-01-21
• Date of Report: 1997-01-20
• Date of Event: 1996-12-29
• Date Mfgr Received: 1997-01-16
• Date Added to Maude: 1997-01-30
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Manufacturer Phone: **
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MILLER-ABBOTT TUBE
• Generic Name: INTESTINAL TUBE
• Product Code: FEF
• Date Received: 1997-01-21
• Model Number: NA
• Catalog Number: 205000XX SIZE UNK
• Lot Number: UNK
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 65382
• Manufacturer: WILLY RUSCH AG
• Manufacturer Address: WILLY RUSCH STRASSE 4-10 KERNEN ROMMEISHAUSEN GM D71394
• Baseline Brand Name: MILLER-ABBOTT TUBE
• Baseline Generic Name: INTESTINAL TUBE
• Baseline Model No: NA
• Baseline Catalog No: 205000XX SIZE UNK
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1997-01-21