BHR UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-12-07 for BHR UNK manufactured by Smith & Nephew, Inc., Orthopaedic Div..

Event Text Entries

[17889240] It was reported that additional surgery was performed due to a surgical error, a marking pin was inadvertently left in the patient and was returned to the or for removal of that pin.
Patient Sequence No: 1, Text Type: D, B5

[17968024] Na
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 1020279-2007-00368
• MDR Report Key: 960061
• Report Source: 07
• Date Received: 2007-12-07
• Date of Report: 2007-11-08
• Date of Event: 2007-08-21
• Date Mfgr Received: 2007-11-09
• Date Added to Maude: 2007-12-13
• 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: 0
• Event Location: 0
• Manufacturer Contact: MRS. MELANIE TRAVIS
• Manufacturer Street: 1450 BROOKS RD.
• Manufacturer City: MEMPHIS TN 38116
• Manufacturer Country: US
• Manufacturer Postal: 38116
• Manufacturer Phone: 9013996233
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BHR
• Generic Name: MARKING PIN
• Product Code: JDD
• Date Received: 2007-12-07
• Model Number: NA
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: B
• Device Sequence No: 1
• Device Event Key: 932687
• Manufacturer: SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
• Manufacturer Address: 1450 BROOKS RD. MEMPHIS TN 38116 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2007-12-07