MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-11-20 for 146-S MAPLE LEAF, SMALL manufactured by Becker Orthopedic Appliance Co.
[127877939]
A review of all return, compliant, and feedback information on the maple leaf? For the past seven years was conducted and no other such narrative was documented. There were zero instances of pressure ulcers, tightness, or fit issues in any of the other cases of the maple leaf being used. I was "instructued" by (b)(6) to add a narrative that this submission was not within 5 business days of receipt due to our firm being in the enrollment process of electronic submission. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[127877940]
A maple leaf? (146-s) was fitted on a patient on, or around, (b)(6) 2018 at (b)(6) hospital (b)(6). The orthotic brace was adjusted for range of motion, rotation, and flexion on, or around, (b)(6) 2018, (b)(6) 2018, and (b)(6) 2018. On (b)(6) 2018, a pressure ulcer was noted on the back edge of the right thigh cuff of the maple leaf?. The patient was wearing the orthotic brace continuously from the fitting of the brace until the discovery of the pressure ulcer. The patient was fitted with the orthotic brace to stabilize a repaired fracture and was in multiple laying, supine, prone, and recumbent positions during their inpatient and outpatient stays.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1824252-2018-00001 |
| MDR Report Key | 8089044 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-11-20 |
| Date Mfgr Received | 2018-10-23 |
| Date Added to Maude | 2018-11-20 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ERICA GUICE |
| Manufacturer Street | 635 EXECUTIVE DR |
| Manufacturer City | TROY MI 48083 |
| Manufacturer Country | US |
| Manufacturer Postal | 48083 |
| Manufacturer Phone | 2485887480 |
| Manufacturer G1 | BECKER ORTHOPEDIC APPLIANCE CO |
| Manufacturer Street | 635 EXECTUIVE DR |
| Manufacturer City | TROY MI 48083 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 48083 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 146-S MAPLE LEAF, SMALL |
| Generic Name | HIP ABDUCTION ORTHOSIS |
| Product Code | ITS |
| Date Received | 2018-11-20 |
| Model Number | 146-S |
| Catalog Number | 146-S |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKER ORTHOPEDIC APPLIANCE CO |
| Manufacturer Address | 635 EXECTUIVE DR TROY MI 48083 US 48083 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-20 |