MAUDE Adverse Event Report: SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LTD ADAPTIC TOUCH¿ NON-ADHERING SILICONE DRESSING; NAD

Model Number ADPTCH

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Date of event: the date of the event is unknown.The event was reported to kci on 29-apr-2019.Device evaluated by mfr: device not returned/ no identifier known.Based on the information provided, it cannot be determined that the partial graft failure is related to the adaptic touch¿ non-adhering silicone dressing.It was unknown how much time elapsed from the glue application to the graft placement.This report is being filed due to possible user error.No additional information is available due to the limited information provided.Device labeling, available in print and online states: indications: adaptic touch¿ non-adhering silicone dressing is designed as a primary wound contact layer for use in the management of dry to heavily exudating, partial and full-thickness chronic wounds including venous ulcers, decubitus (pressure) ulcers and diabetic ulcers, and for traumatic and surgical wounds, donor sites and 1st and 2nd degree burns.Contraindications: adaptic touch¿ non-adhering silicone dressing is not indicated for: surgical implantation.Dressing application: cover with an appropriate absorbent secondary dressing, e.G.Tielle hydropolymer dressing.Adaptic touch¿ may also be suitable for use, under medical supervision, with negative pressure wound therapy (npwt) for the protection of fragile wound structures.

Event Description

On 29-apr-2019, the following information was reported to kci: the patient had a graft placed using glue instead of sutures or stapled in place.Adaptic touch¿ non-adhering silicone dressing was applied with v.A.C.® therapy.Upon performing a dressing change, the adaptic touch¿ dressing allegedly adhered to the graft.The center of the graft was incorporated and only the edges of the graft were adhered to the dressing.It was unknown how much time elapsed from the glue application to the graft placement.On 28-may-2019, the following information was reported to kci by the nurse: the graft was viable with small areas that required re-suturing.The nurse noted a lot number was unavailable as the product was discarded.The adaptic touch¿ dressing lot number was not provided, therefore, a device history review could not be performed.The adaptic touch¿ dressing was confirmed discarded so no product is available for return.

• Brand Name: ADAPTIC TOUCH¿ NON-ADHERING SILICONE DRESSING
• Type of Device: NAD
• Manufacturer (Section D): SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LTD; gargrave; north yorkshire, england BD23 3RX; UK BD23 3RX
• Manufacturer Contact: kirsten emmett ; gargrave; north yorkshire
• MDR Report Key: 8647538
• MDR Text Key: 146284466
• Report Number: 3007663067-2019-00005
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ADPTCH
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2019
• Initial Date FDA Received: 05/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2 YR