IMPROVED JACKSON ESOPHAGEAL DILATOR 34 FR. * 50-7834

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2004-06-17 for IMPROVED JACKSON ESOPHAGEAL DILATOR 34 FR. * 50-7834 manufactured by Pilling Surgical.

MAUDE Entry Details

• Report Number: 2515651-2003-00007
• MDR Report Key: 561380
• Report Source: 06
• Date Received: 2004-06-17
• Date of Event: 2003-12-18
• Date Facility Aware: 2003-12-18
• Date Mfgr Received: 2003-12-22
• Device Manufacturer Date: 1999-02-01
• Date Added to Maude: 2004-12-28
• 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: BRADLEY SEIDEN, MGR
• Manufacturer Street: 200 PRECISION ROAD SUITE 200
• Manufacturer City: HORSHAM PA 19044
• Manufacturer Country: US
• Manufacturer Postal: 19044
• Manufacturer Phone: 2154428892
• 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: IMPROVED JACKSON ESOPHAGEAL DILATOR 34 FR.
• Generic Name: ESOPHAGEAL DILATOR
• Product Code: FAT
• Date Received: 2004-06-17
• Model Number: *
• Catalog Number: 50-7834
• Lot Number: BB9
• ID Number: *
• Device Availability: *
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PILLING SURGICAL
• Manufacturer Address: 200 PRECISION RD. SUITE 200 HORSHAM PA 19044 US 19044
• Baseline Brand Name: JACKSON ESOPHAGEAL DILATOR
• Baseline Generic Name: DILATOR
• Baseline Model No: 50-7834
• Baseline Catalog No: 50-7834
• Baseline Device Family: ESOPHAGEAL DILATORS
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K990935
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0		2004-06-17