MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-05-15 for AIRCAST AIRSELECT, SHORT, XLARGE 01ES-XL manufactured by Djo, Llc.
[145100530]
The device is not available for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[145100531]
It was reported that "when walking on the walkway, a velcro fastener on the forefoot is torn off. The customer lost his balance and crashed with his shoulder onto a parked car trailer, then further onto the road, and injured his left elbow. The customer is 1,90 m tall and weighs (b)(6) kg. He received the walker on (b)(6) 2017, was instructed in its use and received written instructions for use. In the meantime, the customer has been provided with a corresponding orthosis from another manufacturer. " no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2019-00021 |
| MDR Report Key | 8611653 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2019-05-15 |
| Date of Report | 2019-05-15 |
| Date of Event | 2017-08-10 |
| Date Mfgr Received | 2018-09-12 |
| Device Manufacturer Date | 2017-02-21 |
| Date Added to Maude | 2019-05-15 |
| 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. BRIAN BECKER |
| Manufacturer Street | 2900 LAKE VISTA DRIVE |
| Manufacturer City | LEWISVILLE TX 75067 |
| Manufacturer Country | US |
| Manufacturer Postal | 75067 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Street | CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO |
| Manufacturer City | TIJUANA, B.C. 22244, |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRCAST AIRSELECT, SHORT, XLARGE |
| Generic Name | JOINT, ANKLE, EXTERNAL BRACE |
| Product Code | ITW |
| Date Received | 2019-05-15 |
| Model Number | 01ES-XL |
| Lot Number | 170221-BB |
| 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 | 2019-05-15 |