MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-22 for MDS50514-10 manufactured by Medline Industries Inc..
[52724958]
The end user fractured his left tibia on (b)(6) 2016 and was given crutches for ambulation. He was ambulating on various surfaces both inside and outside of his home. He states that on (b)(6), while ambulating in his home, the crutch tip wore through and he fell. He was evaluated by his physician the following day and was told he tore a ligament in his left leg below his tibia. The torn ligament will require surgical repair. The sample was not returned for evaluation. We have no photos of the device. At root cause has not been determined. Due to the reported injury, a medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
[52724959]
Crutch tip wore through, end user fell suffering a torn ligament.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2016-00085 |
| MDR Report Key | 5894974 |
| Date Received | 2016-08-22 |
| Date of Report | 2016-08-22 |
| Date of Event | 2016-08-08 |
| Date Mfgr Received | 2016-08-08 |
| Device Manufacturer Date | 2016-02-01 |
| Date Added to Maude | 2016-08-22 |
| 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JULIE FINLEY |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | CRUTCH |
| Product Code | INP |
| Date Received | 2016-08-22 |
| Catalog Number | MDS50514-10 |
| Lot Number | 74716020004 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2016-08-22 |