MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-07-18 for DEROYAL 13664009 manufactured by Deroyal Induestries, Inc.
[16050833]
The nurse reported that the pt seems to be having a reaction to binder or skin prep. Pt has a raised, reddened rash that has spread across the entire abdomen and also appears on the back around waist area. Hydrocortisone was applied. The nurse has seen this at least five times in the last four months. Product states latex free. Per rn, this type of reaction has been in pts with c-section as well as vaginal deliveries; thus, staff do not believe that there is a reaction to the skin prep used for c-section deliveries because the prep is not used in a vaginal delivery. The pt in this incident has no known allergies.
Patient Sequence No: 1, Text Type: D, B5
[16507543]
The bill of material for the components of the product was reviewed and no material changes to the components were identified for the lot number reported. The appropriate level of skin contact biocompatibility on the materials was confirmed. Sensitization, irritation, cytotoxicity, and latex protein concentration testing were successfully completed and passed. Furthermore, the product does not contain natural rubber latex.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1123071-2013-00005 |
| MDR Report Key | 3246831 |
| Report Source | 06 |
| Date Received | 2013-07-18 |
| Date of Report | 2013-06-24 |
| Date of Event | 2013-05-24 |
| Date Facility Aware | 2013-05-24 |
| Report Date | 2013-06-24 |
| Date Reported to FDA | 2013-06-12 |
| Date Mfgr Received | 2013-06-24 |
| Device Manufacturer Date | 2012-10-01 |
| Date Added to Maude | 2013-07-26 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8659387828 |
| Manufacturer G1 | DEROYAL INDUSTRIES INC |
| Manufacturer Street | 164 GILES HOLLOW RD |
| Manufacturer City | ROSE HILL VA 24281 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 24281 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL |
| Generic Name | MHW - DRESSING, COMPRESSION |
| Product Code | MHW |
| Date Received | 2013-07-18 |
| Returned To Mfg | 2013-07-15 |
| Catalog Number | 13664009 |
| Lot Number | 30007271 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUESTRIES, INC |
| Manufacturer Address | ROSE HILL VA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-18 |