MAUDE Adverse Event Report: COOPERSURGICAL INC. NEO-PREP SM SKIN BARRIER

Model Number 44-8000

Device Problem Mechanical Problem (1384)

Patient Problem Skin Tears (2516)

Event Date 04/11/2023

Event Type  malfunction  

Event Description

Per details reported on incoming (b)(4): "pressure injuries - a couple babies received pressure injuries on the lower half of their upper lip (where the ett exits the mouth).None reported on the area above the lips where the neofit device is actually placed.Neoprep was in use.Reminded that the neofit should not be touching the upper lip or nose & can be trimmed to conform to babies anatomy.Suggested that the device may be placed a little too high and pulling the ett tube into that upper inside lip area.Reiterated that increased activity level of the infant can contribute to tube movement as well as positioning of the baby.They did share that the particular baby that experienced the worst pressure sore was extremely active.Mentioned that neofit is ideal for most infants, but there are those few (due to skin sensitivity, agitation levels, etc.) that it may not be suited for.".

Manufacturer Narrative

Coopersurgical, inc is currently investigating the reported conditon.

Manufacturer Narrative

Based on further review of the reported condition and additonal information received , coopersurgical, inc.Has deemed this incident to be a non reportable event.This complaint file will be evaluated as a standard product complaint investigation.

Event Description

Per details reported on incoming (b)(4)."pressure injuries - a couple babies received pressure injuries on the lower half of their upper lip (where the ett exits the mouth).None reported on the area above the lips where the neofit device is actually placed.Neoprep was in use.Reminded that the neofit should not be touching the upper lip or nose & can be trimmed to conform to babies anatomy.Suggested that the device may be placed a little too high and pulling the ett tube into that upper inside lip area.Reiterated that increased activity level of the infant can contribute to tube movement as well as positioning of the baby.They did share that the particular baby that experienced the worst pressure sore was extremely active.Mentioned that neofit is ideal for most infants, but there are those few (due to skin sensitivity, agitation levels, etc.) that it may not be suited for.".

• Brand Name: NEO-PREP SM SKIN BARRIER
• Type of Device: NEO-PREP SM SKIN BARRIER
• Manufacturer (Section D): COOPERSURGICAL INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 coporate dr.; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 16806353
• MDR Text Key: 313912689
• Report Number: 1216677-2023-00070
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 44-8000
• Device Catalogue Number: 44-8000
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2023
• Initial Date FDA Received: 04/25/2023
• Supplement Dates Manufacturer Received: 04/11/2023
• Supplement Dates FDA Received: 06/06/2023
• 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
• Patient Outcome(s): Hospitalization; Other