MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-02-26 for DEROYAL 46-712 manufactured by Deroyal Industries, Inc..
[3130263]
It was reported that multidex gel was applied to incision on sacral area from a cyst being removed and product ripped butt checks causing bleeding.
Patient Sequence No: 1, Text Type: D, B5
[10524156]
Describe event or problem: it was reported that multidex gel was applied to incision on sacral area from a cyst being removed and product ripped butt cheeks causing bleeding. Deroyal: within the application section of the instructions for use it states to cover with a non-adherent dressing after applying the multidex. This event was determined to be an application error. The customer obtained the product from an outside source and it is unk to deroyal if the ifu was supplied to the time of purchase. As a corrective action it was confirmed that an ifu was provided with the replacement product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2320762-2013-00001 |
| MDR Report Key | 2987939 |
| Report Source | 00 |
| Date Received | 2013-02-26 |
| Date of Report | 2013-02-05 |
| Date of Event | 2013-02-02 |
| Date Facility Aware | 2013-02-02 |
| Report Date | 2013-02-05 |
| Date Reported to Mfgr | 2013-02-05 |
| Date Mfgr Received | 2013-02-05 |
| Device Manufacturer Date | 2012-01-01 |
| Date Added to Maude | 2013-03-18 |
| 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 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 | 1595 HIGHWAY 33 SOUTH |
| Manufacturer City | NEW TAZEWELL TN 37825 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37825 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL |
| Generic Name | MGQ - DRESSING, WOUND AND BURN |
| Product Code | MGQ |
| Date Received | 2013-02-26 |
| Catalog Number | 46-712 |
| Lot Number | 27962701 |
| Device Expiration Date | 2016-12-08 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | NEW TAZEWELL TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-02-26 |