STRYKER QUICK PRESSURE MONITOR SET 295-2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-08-02 for STRYKER QUICK PRESSURE MONITOR SET 295-2 manufactured by Stryker Instruments.

Event Text Entries

[16409172] Trauma patient; unrestrained driver vs tree; multiple serious injuries including bilateral ankle fractures. Splints placed patient vented. Questionable deterioration in circulation to lower extremities; compartment pressures measured and "normal". Two days later, patient required transfer to or for bilateral fasciotomies secondary to bilateral antero/steral compartment syndrome. Patient required several returns to or with eventual right below knee amputation.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 19770
• MDR Report Key: 19770
• Date Received: 1994-08-02
• Date of Report: 1994-01-13
• Date of Event: 1993-10-27
• Date Added to Maude: 1995-02-16
• 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: STRYKER QUICK PRESSURE MONITOR SET
• Generic Name: INTRA-COMPARTMENTAL PRESSURE MONITOR SYSTEM
• Product Code: LXC
• Date Received: 1994-08-02
• Model Number: 295-2
• Lot Number: 93062362
• Device Expiration Date: 1996-01-31
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: B
• Device Sequence No: 1
• Device Event Key: 19671
• Manufacturer: STRYKER INSTRUMENTS
• Manufacturer Address: 4100 EAST MILHAM AVE KALAMAZOO MI 490016197 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Other; 3. Deathisabilit	1994-08-02