MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-05-24 for DEROYAL 72-4101 manufactured by Deroyal Guatemala.
[3527787]
The medical center reported that the neonatal eye covers were causing red irritation on the babies in the elastic area of the product.
Patient Sequence No: 1, Text Type: D, B5
[10797692]
The reported device has been returned to deroyal for eval. There have been no add'l complaints for this part number. The investigation into the root cause has not been completed at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005225477-2013-00008 |
| MDR Report Key | 3142246 |
| Report Source | 06 |
| Date Received | 2013-05-24 |
| Date of Report | 2013-05-01 |
| Date of Event | 2013-05-01 |
| Date Facility Aware | 2013-05-01 |
| Report Date | 2013-05-01 |
| Date Reported to Mfgr | 2013-05-01 |
| Date Mfgr Received | 2013-05-01 |
| Device Manufacturer Date | 2011-03-01 |
| Date Added to Maude | 2013-06-04 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 200 DEBUSK LN |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8659387828 |
| Manufacturer G1 | DEROYAL GUATEMALA |
| Manufacturer Street | KM 20.5 CARRETERA A VILLA CANALES |
| Manufacturer City | VILLA CANALES |
| Manufacturer Country | GT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL |
| Generic Name | FOK - PAD, NEONATAL EEY |
| Product Code | FOK |
| Date Received | 2013-05-24 |
| Catalog Number | 72-4101 |
| Lot Number | 24569859 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL GUATEMALA |
| Manufacturer Address | GT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-05-24 |