MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-12-13 for AIRCAST 01ES-M manufactured by Djo, Llc.
[94699556]
Complaint received that alleges "walking boot deflated and without warning or notice the position of my foot changed in the boot and caused a huge blister on the outside of the foot. It was at the 3 week mark or so that the new boot did the same thing on the right side and deflated again and shifted my foot back to the side of the boot and rubbed another blister. I am not a diabetic but i do have neuropothy in my feet and couldn't feel the injury or the rubbing as it happened. To my surprise at bed time when i took off the boot i discovered the injury. It was this second time that the blister was bigger. As the blister healed i protected it in the boot with padding so it wouldn't rub on the right side of the boot. It was about 7 weeks after getting this second blister that the injury occured. The blister was just all about closed up and nothing there when all of a sudden it got infected. It started out in the am as being "wet" and i didn't understand and put a bandaid on it. That evening when i took off my boot the blister was the size of a quarter and over night it grew to the size of a fifty cent piece. I had the wound lanced right away and ended up in er when the area took off and spread on my foot. It took 6-7 weeks of having the wound packed and certain medicines put on the wound to help it heal. I was seen at a limb preservation office by a dr (b)(6)". Questionnaire not received from customer or clinician. Device not received manufacturer at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2017-00023 |
| MDR Report Key | 7113116 |
| Report Source | CONSUMER |
| Date Received | 2017-12-13 |
| Date of Report | 2017-12-13 |
| Date of Event | 2017-12-01 |
| Date Added to Maude | 2017-12-13 |
| 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 | WILLIAM FISHER |
| Manufacturer Street | 1430 DECISION STREET |
| Manufacturer City | VISTA CA 920819663 |
| Manufacturer Country | US |
| Manufacturer Postal | 920819663 |
| Manufacturer Phone | 7607343126 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Street | CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO |
| Manufacturer City | TIJUANA, 22244 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22244 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRCAST |
| Generic Name | AIRSELECT, SHORT, MEDIUM |
| Product Code | KNP |
| Date Received | 2017-12-13 |
| Returned To Mfg | 2018-01-05 |
| Model Number | 01ES-M |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | 1430 DECISION STREET VISTA CA 920819663 US 920819663 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-13 |