MAUDE Adverse Event Report: MONICA HEALTHCARE LTD MONICA NOVII WIRELESS PATCH SYSTEM; UTERINE ELECTROMYOGRAPHIC MONITOR

Model Number 107-PT-001-1

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abrasion (1689); Superficial (First Degree) Burn (2685)

Event Date 10/05/2019

Event Type  Injury  

Manufacturer Narrative

Ge healthcare's investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Unique identifier: (b)(4).Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported that there was tissue loss and small spots under 3 of the 5 circular gray patch leads where glue is on the patch and redness under all 5 of the patches of approximately 5cm area.Silvadene cream was ordered by the doctor to be applied to the affected areas.Before discharge of the patient, the doctor noted improvement with use of the silvadine cream.Adequate wound healing was noted.

Manufacturer Narrative

This event was reviewed by ge healthcare medical director.The novii patches do not emit heat and there was no malfunction thus a burn reaction is not possible.The clinician determined that the reaction to the patches required medical intervention and prescribed a crã¨me intended for burns which is not meant to treat contact dermatitis or allergic reactions.Despite the chosen cream, the redness and tissue loss showed improvement and no indication of any lasting harm.The potential allergic reaction or contact dermatitis reaction described in the complaint was not life-threatening and would not have caused a permanent impairment or permanent damage to a body function/structure even without the topical treatment given.Thus the reportability criteria have not been met.This event was not reportable.This event was reviewed by ge healthcare medical director.The novii patches do not emit heat and there was no malfunction thus a burn reaction is not possible.The clinician determined that the reaction to the patches required medical intervention and prescribed a crã¨me intended for burns which is not meant to treat contact dermatitis or allergic reactions.Despite the chosen cream, the redness and tissue loss showed improvement and no indication of any lasting harm.The potential allergic reaction or contact dermatitis reaction described in the complaint was not life-threatening and would not have caused a permanent impairment or permanent damage to a body function/structure even without the topical treatment given.Thus the reportability criteria have not been met.This event was not reportable.

• Brand Name: MONICA NOVII WIRELESS PATCH SYSTEM
• Type of Device: UTERINE ELECTROMYOGRAPHIC MONITOR
• Manufacturer (Section D): MONICA HEALTHCARE LTD; unit 8, interchange 25; business park bostocks lane; nottingham NG10 5QG; UK NG10 5QG
• MDR Report Key: 9309369
• MDR Text Key: 166315367
• Report Number: 3006340424-2019-00002
• Device Sequence Number: 1
• Product Code: OSP
• Combination Product (y/n): N
• PMA/PMN Number: K140862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/17/2019

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: Health Professional
• Device Model Number: 107-PT-001-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/22/2019
• Initial Date FDA Received: 11/12/2019
• Supplement Dates Manufacturer Received: 12/12/2019
• Supplement Dates FDA Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1