MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-19 for ADJUSTAFIT BOOT AL056007 manufactured by Breg, Inc..
[98091371]
No product has been returned for evaluation. Investigation of issue already completed resulting in a negligible incidence rate. Manufacturing process improvement already implemented to prevent recurrence.
Patient Sequence No: 1, Text Type: N, H10
[98091372]
Reported incident of sole separating from boot. No report of injury involved with incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028253-2017-00087 |
| MDR Report Key | 7206087 |
| Date Received | 2018-01-19 |
| Date of Report | 2018-01-17 |
| Date Mfgr Received | 2017-12-27 |
| Date Added to Maude | 2018-01-19 |
| 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 | MRS. CAROL EMERSON |
| Manufacturer Street | 2885 LOKER AVENUE EAST |
| Manufacturer City | CARSLBAD CA 92010 |
| Manufacturer Country | US |
| Manufacturer Postal | 92010 |
| Manufacturer Phone | 7607955823 |
| Manufacturer G1 | BREG, INC. |
| Manufacturer Street | 2885 LOKER AVENUE EAST |
| Manufacturer City | CARLSBAD CA 92010 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ADJUSTAFIT BOOT |
| Generic Name | ADJUSTAFIT BOOT |
| Product Code | IQI |
| Date Received | 2018-01-19 |
| Model Number | AL056007 |
| Catalog Number | AL056007 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BREG, INC. |
| Manufacturer Address | 2885 LOKER AVENUE EAST CARLSBAD CA 92010 US 92010 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-19 |