MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2020-03-26 for ACTIV.A.C.? THERAPY SYSTEM WNDACT manufactured by Kinetic Concepts, Inc..
[188495635]
Additional device information for v. A. C.? Granufoam? Dressing lot number 7239966v009: expiration date: 31-oct-2022. Unique identifier (udi) #: (b)(4). Device manufacture date: 08-nov-2019. Based on information provided, it cannot be determined that the alleged maceration is related to the activ. A. C.? Therapy system. Device labeling, available in print and online, states: never leave a v. A. C. ? Dressing in place without active v. A. C. ? Therapy for more than 2 hours. If therapy is off for more than 2 hours, remove the old dressing and irrigate the wound. Either apply a new v. A. C.? Dressing from an unopened sterile package and restart v. A. C.? Therapy; or apply an alternative dressing at the direction of the treating clinician. Ensuring dressing integrity it is recommended that a clinician or patient (in the home) visually check the dressing every two hours to ensure that the foam is firm and collapsed in the wound bed while therapy is active, if not: if you find that the seal is broken and the v. A. C.? Drape has become loose, trim away any loose or moist edges, ensure the skin is dry and then apply new drape strips. Note: if a leak source is identified, patch with additional drape to ensure seal integrity.
Patient Sequence No: 1, Text Type: N, H10
[188495636]
On 25-feb-2020, the following information was reported to kci by the patient: the patient allegedly experienced technical issues with the activ. A. C.? Therapy system and the wound was saturated upon removal of the v. A. C.? Granufoam? Dressing. On 26-feb-2020, the following information was reported to kci by the nurse: the patient allegedly developed maceration that required debridement to resolve the issue. The patient was subsequently placed back on v. A. C.? Therapy. On (b)(6) 2020, the device was tested per quality control procedure by kci service center, and the unit passed the quality control checks and met specifications. On (b)(6) 2020, the device was placed with the patient. On (b)(6) 2020, the device was tested per quality control procedure by kci quality engineering and the unit passed the quality control checks and met specifications. Inspection and testing of the device did not reveal any evidence of an operational malfunction with the unit. On 18-mar-2020, a device history review was performed for v. A. C.? Granufoam? Dressing lot number 7239966v009. All end release testing of the product and packaging met specifications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009897021-2020-00128 |
| MDR Report Key | 9886988 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2007-11-16 |
| Date Added to Maude | 2020-03-26 |
| 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.? THERAPY SYSTEM |
| Generic Name | OMP |
| Product Code | OMP |
| Date Received | 2020-03-26 |
| Returned To Mfg | 2020-02-25 |
| Model Number | WNDACT |
| Lot Number | 7239966V009 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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. Required No Informationntervention | 2020-03-26 |