MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2019-01-04 for FLOWABLE WOUND MATRIX - UNSPECIFIED XXX-FLOWABLE manufactured by Integra Lifesciences Corporation.
[132082146]
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[132082147]
Springer (2017) published "to evaluate the efficacy of an acellular flowable matrix in comparison with a wet dressing for the treatment of patients with diabetic foot ulcers: a randomized clinical trial. " the authors aimed to evaluate the efficacy of an advanced wound matrix (integra flowable wound matrix, integra lifescience corp) for treating wounds with irregular geometries versus a wet dressing in patients with diabetic foot ulcers. Sixty patients with diabetic foot ulcers (grades 3 wagner) were included in this randomized clinical trial. Forty-six cases of diabetic foot ulcers were equally and randomly divided into control and test groups. The first group treated with integra flowable wound matrix, while the control group with a wet dressing. Both groups were evaluated once a week for 6 weeks to value the degree of epithelialization and granulation tissue of the wound. The complete healing rate in the whole study population was 69. 56% (integra flowable wound matrix group, 86. 95%, control group, 52. 17%; p = 0. 001). Amputation and rehospitalization rates were higher in the control group compared to the first group, therefore, the difference was statistically significant. Minor amputations were performed: nine (39. 13%) patients in the integra flowable group and eight (34. 78%) patients in the control group. After 6 weeks, the overall complete healing rate among all patients was 69. 56%. Complete wound healing after 6 weeks (primary endpoint), occurred in 20 patients (86. 95%) of the integra flowable wound matrix group and in 12 patients (52. 17%) of the control group. A significant difference in complete healing was observed between the two groups after 6 weeks. After 6 weeks, 3 of the 23 patients (13. 04%) in the integra flowable group showed no healing, without any clinical sign of inflammation (edema, erythema, increased local temperature, the presence of abscess) and/or laboratory signs of inflammation. Time to healing (secondary endpoint) was between: 29. 73? 9. 27 days in the integra flowable group and 42. 78? 8. 22 days in the control group. Major amputation and rehospitalization rates (safety endpoints) were higher in the control group compared to integra flowable wound matrix group, conclusion: the results of the present study demonstrated the integra flowable tested can be considered an effective adjunctive treatment in the promotion of wound healing in the patients with dfus. The integra flowable used in this study allows the treatment of tunneling/or cavity lesions with an irregular geometry of the diabetic foot, which cannot be effectively treated using other biomaterials in the sheet form. Furthermore, easy application, the absence of adverse effects and a minimally invasive approach by primary intention closure of the lesion, make it appropriate in the management of dfus. The integra flowable wound matrix, was significantly superior, compared to the wet dressing, by promoting the complete healing of diabetic foot ulcers.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1121308-2019-00001 |
| MDR Report Key | 8217541 |
| Report Source | LITERATURE |
| Date Received | 2019-01-04 |
| Date of Report | 2018-12-07 |
| Date Mfgr Received | 2019-01-08 |
| Date Added to Maude | 2019-01-04 |
| 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 Contact | USER VIVIAN NELSON |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Street | 105 MORGAN LANE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08536 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLOWABLE WOUND MATRIX - UNSPECIFIED |
| Generic Name | N/A |
| Product Code | KGN |
| Date Received | 2019-01-04 |
| Catalog Number | XXX-FLOWABLE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | 105 MORGAN LANE 105 MORGAN LANE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-04 |