MAUDE Adverse Event Report: OWENS AND MINOR MEDICHOICE; HOT OR COLD DISPOSABLE PACK

Device Problem Leak/Splash (1354)

Patient Problems Abdominal Pain (1685); Headache (1880); Pain (1994); Fluid Discharge (2686)

Event Date 02/10/2016

Event Type  malfunction  

Event Description

The patient is a middle-aged woman admitted for a right radical nephrectomy under general anesthesia without complication.Upon admission to the general surgical unit, the patient complained of abdominal pain, headache and right neck pain.The patient was medicated for incisional pain initially with iv medication and then transitioned to oral agents.The md was paged for the complaint of neck pain, and a warm pack was ordered.The nurse placed the warm pack in a pillowcase and applied this to the anterior surface of the patient's right shoulder while she was lying supine.The call light was within reach at all times and the patient was using it appropriately.Hourly rounding was being completed; the patient's use of heat was reassessed at regular, more frequent intervals with some relief noted.A safe hand off to the oncoming evening-shift rn included the plan for the patient's pain management.On the evening shift, the patient was tolerating sips of clear liquids, was noted to be alert and oriented x3, the call light was within reach at all times and she was using it appropriately.Hourly rounding was being completed.The warm compress was removed and re-applied approximately three times during the course of the night with a pillowcase to protect the patient's skin.The nurse inspected the patient's skin and noted that the color and integrity of the skin on the patient's back and buttocks were intact, with no breakdown noted.The patient was repositioned onto her left side for increased comfort.While the patient reported some relief from the warm heat, she complained that the medichoice instant warm compress did not stay warm for long.The nurse requested an alternative heating pad.The next day during morning care, the rn noted a small blister on the patient's upper right back.Tegaderm was applied to protect the area.The patient was alert and oriented and that she was applying the warm compress covered by a towel to her neck area.Two days after admission, the cns was consulted for wound care.At that time, the tegaderm was found to be leaking and the blister was no longer intact.On the right posterior shoulder there had been an intact blister.The area was open, superficial 1.5 x 1.0 cm.90 % yellow, 10 % pink.A small amount of serous drainage was noted without odor, undermining, or tunneling.The margin was intact without redness.The cns recommended spandgel hydrogel wafer to right shoulder wound daily to promote moist wound healing and protect.Three days after admission, the area of the patient's right posterior shoulder was noted to be improving with an increase in pink tissue.The wound remained open, superficial ( 1.5 x 1.0 cm on 2/10).80 % yellow, 20 % pink.No drainage, odor, undermining, or tunneling was noted.The wound bed was dry and intact without redness.The wound treatment was changed to bacitracin bid to right shoulder to promote moist wound healing.The patient was discharged with visiting nurse follow up.At 18 days after admission, her skin was noted to be intact during a physical examination.

• Brand Name: MEDICHOICE
• Type of Device: HOT OR COLD DISPOSABLE PACK
• Manufacturer (Section D): OWENS AND MINOR; 9120 lockwood blvd; mechanicsville VA 23116
• MDR Report Key: 5646290
• MDR Text Key: 44933917
• Report Number: 5646290
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/02/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR