MAUDE Adverse Event Report: CAREFUSION ELCTD ADT FOAM RND, RDLCNT, SLD GEL 50/P; ELECTRODE, ELECTROCARDIOGRAPH

Model Number 2009110-050R

Device Problem Detachment Of Device Component (1104)

Patient Problems Sore Throat (2396); Foreign Body In Patient (2687)

Event Date 04/28/2014

Event Type  Injury  

Event Description

The following was reported to carefusion "the complaint is very special, but the cause is the almost invisible plastic backside of the ecg electrodes, and the fact that the plastic is loaded with static electricity and sticks to many surfaces.Especially difficult with latex gloves on.This patient had a laryngeal mask inserted after induction.The plastic backside from (b)(4) stuck to the laryngeal mask, without the anesthetist noticing and ended in this patients throat.The plastic was removed after 4 days by an ent specialist." additional details provided from patient "i was admitted for surgery (b)(6) and had surgery as planned.Immediately after my awakening in the recovery room i noticed that something was wrong in my throat.I notified the nursing staff, they told me that this is normal, and gave me a ice-cream.After returning to the ward i still tried to alert the staff regarding the pain in my throat-something is wrong here i told them.I was discharged from the hospital (b)(6) and had to go to my own gp on (b)(6) when my throat still was not good.My gp gave me some steroids, this did not help at all, and i finally got an acute appointment with an ent specialist (b)(6).The ent specialist found and removed this plastic piece from my throat.I still have this plastic as documentation of this event, i had it in my throat for 4 days, which was a hell for me.I ended up eating 6 morphine and 6 paracetamol tablets a day during this, and still had pain my throat.".

Manufacturer Narrative

(b)(4).The complaint product is not available for evaluation.In addition, the lot code of the product is unknown.A follow-up will be submitted in the event that additional information becomes available.1423507-2014-00024.This report (3010838917-2014-00004) is being submitted as the incorrect report number was inadvertently reported with the initial and follow-up submissions.This follow-up is being submitted only to reflect the accurate manufacturer registration number in the report number.

Manufacturer Narrative

(b)(4): the complaint product is not available for evaluation.In addition, the lot code of the product is unk.A follow-up will be submitted in the event that additional information becomes available.1423507-2014-00024: this report (3010838917-2014-00004) is being submitted as the incorrect report number was inadvertently reported with the initial and follow-up submissions.This follow-up is being submitted only to reflect the accurate mfr registration number in the report number.Additional details provided from patient "i was admitted for surgery (b)(6) and had surgery as planned.Immediately after my awakening in the recovery room i noticed that something was wrong in my throat.I notified the nursing staff, they told me that this is normal, and gave me a ice-cream.After returning to the ward i still tried to alert the staff regarding the pain in my throat- something is wrong here i told them.I was discharged from the hospital (b)(6) and had to go to my gp on (b)(6) when my throat still was not good.My gp gave me some steroids, this did not help at all, and i finally got an acute appointment with an ent specialist (b)(6).The ent specialist found and removed this plastic piece from my throat.I still have this plastic as documentation of this event, i had it in my throat for 4 days, which was a hell for me.I ended up eating 6 morphine and 6 paracetamol tablets a day during this, and still had pain in my throat.".

• Brand Name: ELCTD ADT FOAM RND, RDLCNT, SLD GEL 50/P
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): CAREFUSION ; vernon hills IL
• Manufacturer (Section G): CAREFUSION 2200, INC.
• Manufacturer Contact: jill rittorno ; 75 north fairway dr; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 4620867
• MDR Text Key: 5591422
• Report Number: 3010838917-2014-00004
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K040784
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,foreign,user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 2009110-050R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention