MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-06-01 for SNAP? THERAPY SYSTEM WNDSNP manufactured by Kinetic Concepts, Inc..
[109834381]
Based on the information provided, it cannot be determined that the alleged worsened wound and maceration required medical or surgical intervention. There have been several attempts made to gather additional clinical information, but there has been no response. Device labeling, available in print and online, states: if a wound has been progressing well from dressing change to dressing change but then deteriorates rapidly, consider the following interventions and, where necessary, seek the guidance/expertise of a specialist: check the therapy hour meter to ensure that the actual number of therapy hours received matches the number of recommended therapy hours (22 hours a day). If the number of therapy hours is less than 22 each day, find out why there is a therapy deficit and remedy the situation. Clean wound more thoroughly during dressing changes. Evaluate for signs and symptoms of infection and, if present, treat accordingly. Change dressing often, ensuring that it is being changed at least every 48 hours. Examine the wound and debride as necessary. Debride the wound edges if they appear non-viable or rolled under as this may inhibit the formation of granulation tissue and migration of epithelial cells over an acceptable wound base.
Patient Sequence No: 1, Text Type: N, H10
[109834382]
On (b)(6) 2018, the following information was reported to kci by the customer: after the first dressing change post snap? Therapy system placement on the patient's finger, the wound allegedly appeared worsened and was macerated. The secure ring allegedly "seemed melted. " no additional information is available. A lot number was not provided for the snap? Therapy system therefore a device history review could not be performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009897021-2018-00053 |
| MDR Report Key | 7561605 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-06-01 |
| Date of Report | 2018-06-01 |
| Date of Event | 2018-04-25 |
| Date Mfgr Received | 2018-05-03 |
| Date Added to Maude | 2018-06-01 |
| 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 | STEVEN JACKSON |
| Manufacturer Street | 6203 FARINON DRIVE |
| Manufacturer City | SAN ANTONIO TX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SNAP? THERAPY SYSTEM |
| Generic Name | OKO |
| Product Code | OKO |
| Date Received | 2018-06-01 |
| Model Number | WNDSNP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KINETIC CONCEPTS, INC. |
| Manufacturer Address | SAN ANTONIO TX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-01 |