MAUDE Adverse Event Report: MMJ SA DE CV (USD) SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number 4.0 PED

Device Problems Deformation Due to Compressive Stress (2889); Device Operates Differently Than Expected (2913)

Patient Problem Swelling (2091)

Event Date 02/01/2017

Event Type  malfunction  

Manufacturer Narrative

To date the incident sample has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained a follow-up report will be submitted.

Event Description

Customer reported while in use on a patient, swelling was seen on the patient's skin and the skin became very sensitive.It was reported that redness was also found around the stoma.It was reported a decision was made to remove the tube and replace.It was reported that visual examination of the removed tube revealed that the tube was protruding however; no further details were provided regarding the event.Attempts are being made to gather additional information related to this report.

Manufacturer Narrative

One sample was received for analysis and the reported issue could not be confirmed.A visual inspection was performed and it was observed all the components were assembled according to manufacturing process.There were no protrusions observed in the received sample neither sharp edges nor flashes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SHILEY
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer (Section G): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer Contact: sharon murphy ; 15 hampshire street; mansfield, MA 02048 ; 2034925267
• MDR Report Key: 6375070
• MDR Text Key: 68962887
• Report Number: 2936999-2017-05021
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K945513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4.0 PED
• Device Catalogue Number: 4.0 PED
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 2 YR