SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM * P/N 40-21-317 REV. B

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-07-20 for SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM * P/N 40-21-317 REV. B manufactured by Smiths Medical Asd, Inc.

Event Text Entries

[2832003] At the end of conversion of laparoscopic band to laparoscopic gastric bypass it was noted upon assessment that the patient had developed blisters and erythema on the area just above the nipple line, upper chest wall and bilateral upper arms. The bovie pad site was intact. The surgeon was immediately notified and was present to evaluate. The charge nurse notified the nurse manager. The snuggle warming pad, lot number 2249928 exp 05/2015 and the electrosurgical pad, lot number 2014 were sequestered at the front desk. The equator warming device and the valley lab electrosurgical generator were also sequestered and removed from room by bioengineering. The anesthesia attending was also present and aware of post-operative skin changes.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2674780
• MDR Report Key: 2674780
• Date Received: 2012-07-20
• Date of Report: 2012-07-20
• Date of Event: 2012-07-17
• Report Date: 2012-07-20
• Date Reported to FDA: 2012-07-20
• Date Added to Maude: 2012-07-30
• 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
• 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 Sequence Number: 1

• Brand Name: SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM
• Generic Name: CONVECTIVE WARMER
• Product Code: DWJ
• Date Received: 2012-07-20
• Model Number: *
• Catalog Number: P/N 40-21-317 REV. B
• Lot Number: SUSW 2010 LOT2249928
• ID Number: *
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SMITHS MEDICAL ASD, INC
• Manufacturer Address: 160 WEYMOUTH STREET ROCKLAND MA 02370 US 02370

Device Sequence Number: 2

• Brand Name: UNIVERSAL ELECTROSURGICAL PAD: SPLIT WITH CORD
• Generic Name: ELECTROSURGICAL PATIENT RETURN ELECTRODE
• Product Code: ODR
• Date Received: 2012-07-20
• Model Number: *
• Catalog Number: 9165
• Lot Number: 2014
• ID Number: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: 3M HEALTH CARE
• Manufacturer Address: 3M CENTER ST. PAUL MN 55144100 US 55144 1000

Device Sequence Number: 3

• Brand Name: LEVEL 1 EQUATOR CONVECTIVE WARMER
• Generic Name: THERMAL REGULATING SYSTEM
• Product Code: DWJ
• Date Received: 2012-07-20
• Model Number: EQ-5000
• Catalog Number: 300301
• Lot Number: *
• ID Number: *
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: SMITHS MEDICAL ASD, INC.
• Manufacturer Address: 160 WEYMOUTH STREET ROCKLAND MA 02370 US 02370

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-07-20