MAUDE Adverse Event Report: COVIDIEN 6003 LG BABY SHADE 50/B 200/C

Model Number MI00625

Device Problems Sticking (1597); Material Integrity Problem (2978)

Patient Problem Skin Irritation (2076)

Event Date 01/14/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 02/17/2016.An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a baby shade.The customer reports that the phototherapy glasses do not fit to the ocular area so they do not protect the patient from the harmful effects caused by phototherapy.The phototherapy glasses are stuck on the baby's skin and they have to unstick them every 3 hours when the baby is fed.Sometimes phototherapy glasses also stick and is dangerous to the premature skin.

Manufacturer Narrative

The sample received with this complaint consisted of one unopened pouch with phototherapy eye protector (large) part number: mi00625.The unused mi00625 part was 100% visually inspected and met all requirements of product construction.Consequently the reported condition could not be confirmed.The observed rate of occurrence for this issue does not exceed the expected rate of occurrence as documented in the risk management file.The most probable root cause of phototherapy glasses not fitting to the ocular area is in improper use of the product.It is worth noting that paying strict attention to product application utilizing both the hydrogel and provided headband straps in the correct positioning as identified on the pouch will increase product efficacy.It is important to note that covidien offers two sizes of baby shades: small (product id mi00575) and large (product id mi00625).This customer complaint is on the large baby shades which is meant to be used on larger babies and not on smaller premature baby.The small size of baby shades is 2.9cm x 11.4 cm, whereas the large is 3.8cm x 14cm.The larger size of baby shades is made to fit on bigger babies.Additionally, as identified on the insert provided with the product it is a single use product and is not designed for re-applications.Since this complaint is unconfirmed and no complaint trend exists and a specific root cause for the occurrence cannot be identified, no corrective action is required at this time.This complaint will be recorded for tracking and trending purposes.

• Brand Name: 6003 LG BABY SHADE 50/B 200/C
• Type of Device: BABY SHADE
• Manufacturer (Section D): COVIDIEN; 215 herbert street; gananoque ; CA
• Manufacturer (Section G): COVIDIEN; 215 herbert street; gananoque K7G 2 Y7; CA K7G 2Y7
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5442236
• MDR Text Key: 39025077
• Report Number: 9681860-2016-00001
• Device Sequence Number: 1
• Product Code: FOK
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MI00625
• Device Catalogue Number: MI00625
• Device Lot Number: 525801X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1