MEDOVATION ESOPHAGEAL DILATOR 121058 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-03-30 for MEDOVATION ESOPHAGEAL DILATOR 121058 * manufactured by Medovations.

Event Text Entries

[129170] Pt had laparoscopic nissen fundoplication which converted to a laparotomy due to esophageal perforation after intra-operative dilation. The pt had dilators passed in a graded fashion started with 48 to 58. Fifty-six was passed easily into the esophagus into the stomach. When size 58 dilator was passed the tip of the dilator perforated the esophagus in the posterior wall on the right side. During the laparotomy the repair was performed on the esophagus. Gastrostomy and feeding jejunostomy were also inserted.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 218667
• MDR Report Key: 218667
• Date Received: 1999-03-30
• Date of Report: 1999-03-12
• Date of Event: 1999-03-03
• Date Facility Aware: 1999-03-03
• Report Date: 1999-03-12
• Date Reported to Mfgr: 1999-03-12
• Date Added to Maude: 1999-04-15
• 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
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MEDOVATION ESOPHAGEAL DILATOR
• Generic Name: MAHONEY DILATOR #58
• Product Code: FAT
• Date Received: 1999-03-30
• Model Number: 121058
• Catalog Number: *
• Lot Number: 6/93
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 212073
• Manufacturer: MEDOVATIONS
• Manufacturer Address: W194N11340 MCCORMICK DRIVE GERMANTOWN WI 53022 US
• Baseline Brand Name: MEDOVATION ESOPHAGEAL DILATOR
• Baseline Generic Name: MAHONEY DILATOR #58
• Baseline Model No: 121058
• Baseline Catalog No: *
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	1999-03-30