MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-09 for SHOE DH OFFLOAD MD 10341 manufactured by Ossur Americas.
[123195722]
According to the patient, the velcro hook broke and became undone, which caused a fall and an injury to the patient's ankle. The patient mentioned that he did seek medical attention in form of x-ray. The product was not returned, and it is difficult to pinpoint the failure based on the customer description as there are two hook and loop straps on the product. Therefore, there are a variety of factors that must be considered regarding why the hook didn't adhere properly to the loop. These factors may include, shoe size too small, loop worn out due to repeated use, user error during donning. This is a newly identified failure; therefore, no action is required at this moment. Attempts have been made to contact the customer for additional information regarding what, if any, injury occurred. No reply from customer. Customer service followed up to get patient status on many occasions with no response from patient. Dates follow up was performed: (b)(6) 2018, (b)(6) 2018 - (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[123195723]
Patient claimed he fell, when the velcro failure on the dh offloading post-op shoe and had to seek medical attention in form of an xray for his ankle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2085446-2018-00003 |
| MDR Report Key | 7949768 |
| Date Received | 2018-10-09 |
| Date of Report | 2018-07-17 |
| Date Mfgr Received | 2018-07-17 |
| Date Added to Maude | 2018-10-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS CRYSTAL SWAFFORD |
| Manufacturer Street | NO. 11, TSU-CHIANG 1ST ROAD, |
| Manufacturer City | NANTOU CITY NANTOU, TAIWAN 540 |
| Manufacturer Country | TW |
| Manufacturer Postal | 540 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SHOE DH OFFLOAD MD |
| Generic Name | SHOE DH OFFLOAD MD |
| Product Code | IPG |
| Date Received | 2018-10-09 |
| Model Number | 10341 |
| Catalog Number | 10341 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | OSSUR AMERICAS |
| Manufacturer Address | 27051 TOWNE CENTRE DRIVE FOOTHILL RANCH CA 92610 US 92610 |
| Brand Name | SHOE DH OFFLOAD MD |
| Generic Name | SHOE DH OFFLOAD MD |
| Product Code | IPG |
| Date Received | 2018-10-09 |
| Model Number | 10341 |
| Catalog Number | 10341 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR AMERICAS |
| Manufacturer Address | 27051 TOWNE CENTRE DRIVE FOOTHILL RANCH CA 92610 US 92610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-09 |