MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-10-15 for CURITY OIL EMULSION DSG 3X8 PKG/3 6115 manufactured by Covidien.
[3950015]
It was reported to covidien on (b)(6) 2013 that a customer had an issue with an emulsion dressing. The customer reports that the dressing was placed on a wound on her lower back, between the wound and a wound vac dressing. The patient stated they had a chronic staph infection. The patient stated that the skin grew around the dressing, they had discovered that the dressing was not removed and her surgeon cut it out of the wound. The patient stated that they are not sure if all of the dressing was able to be removed. The patient stated the dressing was in place for one month. The customer further reported she is waiting for her health insurance company to approve a ct scan that is being ordered by her wound care physician. The customer stated that last friday, (b)(6) 2013, her wound culture report still reported a staph infection. They have not yet been able to determine if this product is still embedded in the wound. The wound is still closing and the customer stated that she was told that if the opening of the wound closes, that she will need exploratory surgery to look for more foreign body. The customer reports as of last friday (b)(6) 2013, she was placed on another course of iv antibiotics for at least another 3 weeks.
Patient Sequence No: 1, Text Type: D, B5
[11446199]
An investigation is underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1018120-2013-00007 |
| MDR Report Key | 3430376 |
| Report Source | 04 |
| Date Received | 2013-10-15 |
| Date of Report | 2013-10-03 |
| Date Mfgr Received | 2013-10-03 |
| Date Added to Maude | 2013-11-25 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELAINE BISHOP |
| Manufacturer Street | 15 HAMPSHIRE ST |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524686 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 1430 MARVIN GRIFFIN RD. |
| Manufacturer City | AUGUSTA GA 30906 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30906 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CURITY OIL EMULSION DSG 3X8 PKG/3 |
| Generic Name | EMULSION DRESSING |
| Product Code | GEL |
| Date Received | 2013-10-15 |
| Model Number | 6115 |
| Catalog Number | 6115 |
| Lot Number | 130000982762 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 1430 MARVIN GRIFFIN RD. AUGUSTA GA 30906 US 30906 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-10-15 |