MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-25 for ACTIV.A.C.? ION PROGRESS? REMOTE THERAPY MONITORING SYSTEM WNDARM manufactured by Kinetic Concepts, Inc..
[188494958]
Based on information provided, it cannot be determined that the alleged hospitalization, sepsis and c-diff are related to the activ. A. C.? Ion progress? Remote therapy monitoring system. Kci has made multiple unsuccessful attempts to obtain additional clinical information. Device labeling, available in print and online, states: infected wounds should be monitored closely and may require more frequent dressing changes than non-infected wounds, dependent upon factors such as wound conditions, treatment goals. Refer to dressing application instructions (found in v. A. C.? Dressing cartons) for details regarding dressing change frequency. As with any wound treatment, clinicians and patients/caregivers should frequently monitor the patient's wound, periwound tissue and exudate for signs of infection, worsening infection, or other complications. Some signs of infection are fever, tenderness, redness, swelling, itching, rash, increased warmth in the wound or periwound area, purulent discharge or strong odor. Infection can be serious, and can lead to complications such as pain, discomfort, fever, gangrene, toxic shock, septic shock and/or fatal injury. Some signs or complications of systemic infection are nausea, vomiting, diarrhea, headache, dizziness, fainting, sore throat with swelling of the mucus membranes, disorientation, high fever, refractory and/or orthostatic hypotension or erythroderma (a sunburn-like rash). If there are any signs of the onset of systemic infection or advancing infection at the wound site, contact the treating physician immediately to determine if v. A. C.? Therapy should be discontinued. Precautions the v. A. C.? Therapy system will not be effective in addressing complications associated with the following: ischemia to the incision or incision area. Untreated or inadequately treated infection. Inadequate hemostasis of the incision. Cellulitis of the incision area.
Patient Sequence No: 1, Text Type: N, H10
[188494959]
On 24-feb-2020, the following information was reported to kci by the family member: the patient was currently in the hospital allegedly due to sepsis of unknown origin. The patient returned home with clostridium difficile (c-diff) and the family member thinks the sepsis may be related to that. The lab results have not been received to confirm. A device evaluation for activ. A. C.? Ion progress? Remote therapy monitoring system serial number (b)(4) is pending completion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009897021-2020-00119 |
| MDR Report Key | 9878958 |
| Report Source | OTHER |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2018-08-23 |
| Date Added to Maude | 2020-03-25 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. STEVEN JACKSON |
| Manufacturer Street | 6203 FARINON DRIVE |
| Manufacturer City | SAN ANTONIO, TX |
| Manufacturer Country | US |
| Manufacturer Phone | 2556438 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACTIV.A.C.? ION PROGRESS? REMOTE THERAPY MONITORING SYSTEM |
| Generic Name | OMP |
| Product Code | OMP |
| Date Received | 2020-03-25 |
| Returned To Mfg | 2020-03-16 |
| Model Number | WNDARM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KINETIC CONCEPTS, INC. |
| Manufacturer Address | 6203 FARINON DRIVE SAN ANTONIO, TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2020-03-25 |