MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-27 for ACTIV.A.C.? ION PROGRESS? REMOTE THERAPY MONITORING SYSTEM WNDARM manufactured by Kinetic Concepts, Inc..
[188507602]
Unique identified (udi) for v. A. C.? Granufoam? Dressing lot number 7062886v009: (b)(4). Based on information provided, it cannot be determined that the wound edges rolling inwards is related to the activ. A. C.? Ion progress? Remote therapy monitoring system. It is unknown if and what medical or surgical intervention was required. Kci has made multiple unsuccessful attempts to obtain additional clinical information. Device labeling, available in print and online, states: deterioration of the wound 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: -examine the wound and debride as necessary. Debride the wound edges if the 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. Minimal changes in wound size cut the foam slightly smaller than the wound edges for wounds with little depth, to enhance inward epithelial migration. Do not allow the wound edges to roll downward during v. A. C.? Therapy.
Patient Sequence No: 1, Text Type: N, H10
[188507623]
On 27-feb-2020, the following information was reported to kci by the patient: on (b)(6) 2020, the patient went on a v. A. C.? Therapy break allegedly due to the wound being sore. Stated a different nurse dressed the wound and thinks the soreness was due to that. The patient no longer feels sore since v. A. C.? Therapy stopped. The nurse recommended to see the plastic surgeon allegedly due to the wound edges rolling inwards. A device evaluation of the activ. A. C.? Ion progress? Remote therapy monitoring system is currently pending completion. A device history record review for the v. A. C.? Granufoam? Dressing lot number 7062886v009 is currently pending completion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009897021-2020-00130 |
| MDR Report Key | 9892294 |
| Report Source | CONSUMER |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2019-10-01 |
| Date Added to Maude | 2020-03-27 |
| 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 | 2020-03-27 |
| Model Number | WNDARM |
| Lot Number | 7062886V009 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Other | 2020-03-27 |