MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-15 for DEROYAL ELASTIC BANDAGE 31-486 manufactured by Deroyal Industries, Inc..
[142237532]
Deroyal elastic bandages with debris in sterile package. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085900 |
| MDR Report Key | 8518982 |
| Date Received | 2019-04-15 |
| Date of Report | 2019-04-11 |
| Date of Event | 2019-04-11 |
| Date Added to Maude | 2019-04-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DEROYAL ELASTIC BANDAGE |
| Generic Name | BANDAGE, ELASTIC |
| Product Code | FQM |
| Date Received | 2019-04-15 |
| Catalog Number | 31-486 |
| Lot Number | 48904201 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-15 |