JOHNSON & JOHNSON * 7333

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-26 for JOHNSON & JOHNSON * 7333 manufactured by Johnson & Johnson Hosp Products.

Event Text Entries

[48548] Pt injured r forearm after fall from monkey bars. X-ray of wrist (3 views) documents minimally angulated distal r radial fracture. Dr. Applied a sugar-tong splint and recommended pt be seen by orthopaedic physician in 1 week. Appointment made by office for day 11 after injury. Splint was removed at office 9/18/94. Skin inspection revealed blisters and abrasions. Child had not reported itching or burning under cast.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 86591
• MDR Report Key: 86591
• Date Received: 1995-02-09
• Date of Report: 1994-09-15
• Date of Event: 1994-08-29
• Date Facility Aware: 1994-09-08
• Report Date: 1994-09-15
• Date Reported to Mfgr: 1994-09-21
• Date Added to Maude: 1997-04-28
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: JOHNSON & JOHNSON
• Generic Name: J-SPLINT-PLASTER ROLE IMMOBILIZE
• Product Code: FYH
• Date Received: 1995-01-26
• Model Number: *
• Catalog Number: 7333
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: 11 DAY
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 85777
• Manufacturer: JOHNSON & JOHNSON HOSP PRODUCTS
• Manufacturer Address: P O BOX 400 NEW BRUSWICK NJ 08903 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1995-02-09