DISP PNCL W/HLSTR BULKPAK E2515HGNSB

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-19 for DISP PNCL W/HLSTR BULKPAK E2515HGNSB manufactured by Covidien Lp.

Event Text Entries

[39092774] (b)(4). To date, the incident sample has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10

[39092775] The customer reported that the pencil button was sticking in the on position. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1717344-2016-00148
• MDR Report Key: 5448433
• Date Received: 2016-02-19
• Date of Report: 2016-02-12
• Date of Event: 2016-02-04
• Date Mfgr Received: 2016-02-12
• Date Added to Maude: 2016-02-19
• 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: SHARON MURPHY
• Manufacturer Street: 5920 LONGBOW DRIVE
• Manufacturer City: BOULDER CO 80301
• Manufacturer Country: US
• Manufacturer Postal: 80301
• Manufacturer Phone: 2034925267
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: DISP PNCL W/HLSTR BULKPAK
• Generic Name: ES ACCESSORY, NON-STERILE
• Product Code: BWA
• Date Received: 2016-02-19
• Model Number: E2515HGNSB
• Catalog Number: E2515HGNSB
• Lot Number: 52520262X
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COVIDIEN LP
• Manufacturer Address: 5920 LONGBOW DRIVE BOULDER CO 80301 US 80301

Patients

Patient Number	Treatment	Outcome	Date
1	0		2016-02-19