MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-17 for 6003 LG BABY SHADE 50/B 200/C MI00625 manufactured by Covidien.
[39025077]
Submit date: 02/17/2016. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[39025078]
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.
Patient Sequence No: 1, Text Type: D, B5
[44909862]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9681860-2016-00001 |
| MDR Report Key | 5442236 |
| Date Received | 2016-02-17 |
| Date of Report | 2016-02-05 |
| Date of Event | 2016-01-14 |
| Date Mfgr Received | 2016-05-10 |
| Date Added to Maude | 2016-02-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | THOM MCNAMARA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524811 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 215 HERBERT STREET |
| Manufacturer City | GANANOQUE K7G 2Y7 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | K7G 2Y7 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 6003 LG BABY SHADE 50/B 200/C |
| Generic Name | BABY SHADE |
| Product Code | FOK |
| Date Received | 2016-02-17 |
| Model Number | MI00625 |
| Catalog Number | MI00625 |
| Lot Number | 525801X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 215 HERBERT STREET GANANOQUE CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-17 |