MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-07-24 for CURASOL WOUND DRESSING NON-STERILE 3 OZ TUBE manufactured by Dpt Laboratories, Ltd..
[22059859]
Passed away 4 years ago [death]. Case description: on (b)(6) 2015, a spontaneous report was received from a consumer regarding a female of an unspecified age, who was being treated with curasol wound dressing non-sterile 3 oz tube (dressing wound and burn, hydrogel). Medical history included colostomy and ulcers around colostomy bag concomitant products were not reported. On an unspecified date, the pt started treatment with curasol wound dressing non-sterile 3 oz tube at an unspecified dose and frequency to ulcers around her colostomy bag. On an unspecified date in 2011 (reported as 4 years ago), after starting the product, the pt passed away. The reporter declined to provide add'l info.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628114-2015-00001 |
| MDR Report Key | 4943451 |
| Report Source | 04 |
| Date Received | 2015-07-24 |
| Date of Report | 2015-06-29 |
| Date of Event | 2011-01-01 |
| Date Mfgr Received | 2015-06-29 |
| Date Added to Maude | 2015-07-28 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. BRENDA HORN, ASSOC., DIR. |
| Manufacturer Street | 3909 HULEN STREET |
| Manufacturer City | FORT WORTH TX 76107 |
| Manufacturer Country | US |
| Manufacturer Postal | 76107 |
| Manufacturer Phone | 8173023905 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 3909 HULEN STREET |
| Manufacturer City | FORT WORTH TX 76107 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 76107 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CURASOL WOUND DRESSING NON-STERILE 3 OZ TUBE |
| Product Code | MGQ |
| Date Received | 2015-07-24 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DPT LABORATORIES, LTD. |
| Manufacturer Address | FORT WORTH TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2015-07-24 |