MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 1997-10-09 for AIRCAST, INC. 01P-S manufactured by Aircast, Inc..
[101404]
84 yr. Old woman was fitted with an aircast pneumatic walker. Aircells may have been overinflated. Patient later developed fluid filled blisters. Patient apparently was non communicative with alzheimer's and as a nursing home resident apparently did not have the benefit of frequent visual checks as per instructions of the orthotist.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2242894-1997-90001 |
| MDR Report Key | 125363 |
| Report Source | 00,05 |
| Date Received | 1997-10-09 |
| Date of Event | 1997-09-12 |
| Date Mfgr Received | 1997-09-12 |
| Date Added to Maude | 1997-10-14 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRCAST, INC. |
| Generic Name | WALKING BRACE |
| Product Code | IQP |
| Date Received | 1997-10-09 |
| Model Number | 01P-S |
| Catalog Number | 01P-S |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 122719 |
| Manufacturer | AIRCAST, INC. |
| Manufacturer Address | 92 RIVER RD. SUMMIT NJ 079020709 US |
| Baseline Brand Name | PNEUMATIC WALKER |
| Baseline Generic Name | WALKING BRACE |
| Baseline Model No | 01P-S |
| Baseline Catalog No | 01P-S |
| Baseline ID | * |
| Baseline Device Family | WALKING BRACE |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-10-09 |