MAUDE Adverse Event Report: 3M HEALTH CARE 3M NOVAPLUS LOWER BODY BLANKET; SYSTEM, THERMAL REGULATING

Model Number 42534

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Partial thickness (Second Degree) Burn (2694)

Event Date 11/06/2014

Event Type  Injury  

Event Description

A female patient who had gallbladder surgery alleged that she received 2nd degree burns on her breasts, inner thighs/buttocks, and vagina.The patient alleged she went to a wound care specialist outside of the hospital where a diagnosis of "likely 2nd degree burns" was made.The customer was instructed to clean the areas, apply an unidentified ointment, and cover the sites with gauze.She further alleged that she developed a skin infection for which an unidentified oral antibiotic was prescribed.The hospital was contacted in regard to this reported event concerning patient by a 3m representative.They had no record of the injuries alleged by the patient.The hospital contact believes the injury on the breast "could be related" to the adhesive on blanket but indicated they would need to investigate the matter further.

Manufacturer Narrative

The lot number was not provided.Without the lot number the expiration date and manufacturer date can not be determined.Initial reporter: patient did not provide e-mail address.Note: not able to find an acceptable code for the results.Failure to follow instructions - a device problem related to the user not following the manufacturer's instructions.It was noted that the hospital used a non 3m warming unit with the 3m warming blanket.The 3m warming blanket does include the following warning statement: "warning: do not use this blanket with any other device other than a 3m bair hugger warming unit.Thermal injury may result." end of report.

• Brand Name: 3M NOVAPLUS LOWER BODY BLANKET
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave.; st. paul MN 55144 100
• Manufacturer Contact: linda johnsen ; 3m center, bldg. 275-5w-06; st. paul, MN 55144-1000 ; 6517374376
• MDR Report Key: 4381466
• MDR Text Key: 20978199
• Report Number: 2110898-2014-00089
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060865
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 42534
• Device Catalogue Number: 42534
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NEPTUNE WARMING UNIT - CATALOG NUMBER 922970.
• Patient Outcome(s): Other
• Patient Age: 59 YR