MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-05-22 for DERMACLOSE 204010-K 580100001011 manufactured by Baxter Healthcare Corporation.
[108951545]
The sample was not returned therefore, a sample analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[108951546]
A patient experienced a worsening condition in their abdominal wound after a derma close device was applied to the wound for seven days. The size of the wound prior to derma close placement was measured at 6 cm in length and 5 cm in width. Loban was placed under the anchors and adaptic was placed inside the wound. At the time of removal of the derma close for wound closing, the wound was noted to have approximated slightly, reported as the wound "was in worse shape than when the derma close was placed and was not sure if the skin would even hold sutures". The physician noted tissue maceration at the site of the anchors. The wound was closed with a nylon suture. The patient outcome was not reported. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2018-03079 |
| MDR Report Key | 7535084 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-05-22 |
| Date of Report | 2018-05-22 |
| Date of Event | 2018-04-24 |
| Date Mfgr Received | 2018-04-25 |
| Date Added to Maude | 2018-05-22 |
| 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 | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242702068 |
| Manufacturer G1 | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Street | SYNOVIS SURGICAL INNOVATIONS 2575 UNIVERSITY AVE. W |
| Manufacturer City | SAINT PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55144 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DERMACLOSE |
| Generic Name | CONTINUOUS EXTERNAL SKIN EXPANDER |
| Product Code | MKY |
| Date Received | 2018-05-22 |
| Model Number | 204010-K |
| Catalog Number | 580100001011 |
| Lot Number | 079118717A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | SAINT PAUL MN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-22 |