ORTHOSORB ABSORBABLE PIN 84-1050

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 1998-11-11 for ORTHOSORB ABSORBABLE PIN 84-1050 manufactured by Johnson & Johnson Professional, Inc..

Event Text Entries

[18191777] Following bunionectomy the pt developed an infection which the hosp believes may have been caused by the pin.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1219655-1998-00207
• MDR Report Key: 196255
• Report Source: 06
• Date Received: 1998-11-11
• Date of Report: 1998-11-10
• Date Mfgr Received: 1998-10-21
• Date Added to Maude: 1998-11-13
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ORTHOSORB ABSORBABLE PIN
• Generic Name: ABSORBABLE PIN
• Product Code: MBJ
• Date Received: 1998-11-11
• Model Number: NA
• Catalog Number: 84-1050
• Lot Number: 198BE
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Implant Flag: Y
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 190674
• Manufacturer: JOHNSON & JOHNSON PROFESSIONAL, INC.
• Manufacturer Address: 325 PARAMOUNT DR. RAYNHAM MA 02767 US
• Baseline Brand Name: ORTHOSORB ABSORBABLE PIN
• Baseline Generic Name: ABSORBABLE PIN
• Baseline Model No: NA
• Baseline Catalog No: 84-1050
• Baseline ID: *
• Baseline Device Family: ORTHOSORB ABSORBABLE PIN
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K901456
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1998-11-11