MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2012-12-14 for BREG POST-OP SHOE 1118L manufactured by Breg, Inc..
[3097613]
On (b)(4) 2012, breg, inc received notice from an attorney that a patient (his client) who was using the breg post-op shoe alleges to have fallen and injured herself when the sole of the post-op shoe broke away from the main body of the shoe. The patient had wart surgery on her right heel on (b)(6) 2012 and was given a breg post-op shoe after the surgery. On (b)(6) 2012, the patient was sitting in her kitchen and when she attempted to stand up, she asserts that the post-op shoe separated and the sole came apart from the body of the shoe. The patient claims that she then fell to the ground fracturing her opposite left ankle. The patient sought medical attention at (b)(6) hospital where an x-ray confirmed that her ankle was fractured. The patient's attorney indicated that the shoe would not be returned for evaluation by breg but he has provided pictures of the shoe.
Patient Sequence No: 1, Text Type: D, B5
[10288196]
Device not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028253-2012-00028 |
| MDR Report Key | 2874496 |
| Report Source | 00 |
| Date Received | 2012-12-14 |
| Date of Report | 2012-12-14 |
| Date of Event | 2012-11-05 |
| Date Mfgr Received | 2012-11-15 |
| Date Added to Maude | 2013-03-20 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. CAROL EMERSON |
| Manufacturer Street | 2885 LOKER AVENUE EAST |
| Manufacturer City | CARLSBAD CA 92010 |
| Manufacturer Country | US |
| Manufacturer Postal | 92010 |
| Manufacturer Phone | 7607955823 |
| Manufacturer G1 | BREG, INC. |
| Manufacturer Street | 2885 LOKER AVE. E. |
| 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 | 3 |
| Brand Name | BREG POST-OP SHOE |
| Generic Name | POST-OP SHOE |
| Product Code | IPG |
| Date Received | 2012-12-14 |
| Model Number | 1118L |
| Catalog Number | 1118L |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2012-12-14 |