MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-01-06 for AIRCAST 01EP-L manufactured by Djo, Llc.
[35161409]
Not returned.
Patient Sequence No: 1, Text Type: N, H10
[35161410]
Complaint received that alleges "received the boot six weeks after his surgery. Once he was released to start weight bear on his leg he went to (b)(6) on (b)(6) 2015, while walking he started to feel rubbing over the area where his incision was healing. He stopped wearing the boot immediately and went in the water. On (b)(6) 2015 he went to the er complaining of redness and infection on his incision site. He says that he had to have multiple surgeries because of the infection over his surgical site. He claims that the doctors told him that the boot caused the infection". Questionnaire was not received from clinician and/or patient. Device not returned to manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2016-00001 |
| MDR Report Key | 5347621 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-01-06 |
| Date of Report | 2016-01-06 |
| Date of Event | 2015-11-19 |
| Date Mfgr Received | 2015-12-23 |
| Date Added to Maude | 2016-01-06 |
| 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 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Manufacturer Phone | 7607313126 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Street | CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO |
| Manufacturer City | TIJUANA, MEXICO 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, ELITE, LARGE |
| Product Code | IPG |
| Date Received | 2016-01-06 |
| Model Number | 01EP-L |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Required No Informationntervention | 2016-01-06 |