DEPUY 0 2759-03-054

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-04-11 for DEPUY 0 2759-03-054 manufactured by *.

Event Text Entries

[16268823] Catheter sheared prior to complete insertion.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1021595
• MDR Report Key: 326771
• Date Received: 2001-04-11
• Date of Report: 2001-03-06
• Date of Event: 2001-03-06
• Date Added to Maude: 2001-04-17
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: DEPUY
• Generic Name: T-SAW CATHETER
• Product Code: HSO
• Date Received: 2001-04-11
• Returned To Mfg: 2001-03-06
• Model Number: 0
• Catalog Number: 2759-03-054
• Lot Number: RJ5PL1000
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 316174
• Manufacturer: *
• Manufacturer Address: 325 PARAMOUNT DR RAYNHAM MA 02767 US

Device Sequence Number: 2

• Brand Name: DEPUY
• Generic Name: T SAW (SAW) WIRE
• Product Code: HSO
• Date Received: 2001-04-11
• Returned To Mfg: 2001-03-06
• Model Number: *
• Catalog Number: 2759-02-054
• Lot Number: RJ5PS1003
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 316176
• Manufacturer: *
• Manufacturer Address: 325 PARAMOUNT DR RAYNHAM MA 02767 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2001-04-11