MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-05-17 for EZ CLEAN ECONOMY GAIT BELT 6545 manufactured by Posey Company.
[75368322]
The returned device was evaluated following the instructions for use and all functional specifications were met. The cam buckle has no sharp edges that could contribute to the reported issue as the edges are rounded, and the back surface is smooth. The literature or intended for use for this product indicates to adjust the belt so it is snug, but not uncomfortable for the patient. In addition, the caregiver has to make sure that he/she can slide his/her open hand (flat) between the belt and patient. Skin tear are widely seen in elderly individuals who's skin is already compromised due to age and/or illness (clinical management (b)(6) 2013). Additionally, the ifu states "always check for skin integrity, proper circulation and range of motion when the belt is in use. Ensure that the belt is secure and does not compromise the patient? S medical condition and does not interfere with tubes, lines or other equipment. " at this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device. A review of the complaint database did not reveal any similar allegations. Therefore, no corrective or preventative actions are necessary. All complaints are trended and reviewed by management on a monthly basis. As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[75368323]
Customer alleged the gait belt clasp is causing skin tears. The allegation was based on hearsay between sister hospitals and no actual evidence (pictures or medical records) were provided and no one with direct knowledge of the event was available to confirm the event. In addition, the reported serious injury could not be confirmed. The date the issue was discovered is not known.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2017-00020 |
| MDR Report Key | 6572985 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-05-17 |
| Date of Report | 2017-04-24 |
| Date Mfgr Received | 2017-04-24 |
| Device Manufacturer Date | 2017-03-08 |
| Date Added to Maude | 2017-05-17 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | WILLIAM HINCY |
| Manufacturer Street | POSEY COMPANY 5635 PECK ROAD |
| Manufacturer City | ARCADIA CA 91006 |
| Manufacturer Country | US |
| Manufacturer Postal | 91006 |
| Manufacturer Phone | 6264433143 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EZ CLEAN ECONOMY GAIT BELT |
| Generic Name | AID, TRANSFER |
| Product Code | IKX |
| Date Received | 2017-05-17 |
| Model Number | 6545 |
| Catalog Number | 6545 |
| Lot Number | UNK |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POSEY COMPANY |
| Manufacturer Address | 5635 PECK RD. ARCADIA CA 91006 US 91006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-05-17 |