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 2016-11-23 for SINGLE PATIENT USE GAIT BELT 6556 manufactured by Posey Company.
[60873726]
Product was requested to be returned for evaluation and has not been received. This report is based solely on the customer's reported issue. The instructions for use state "always inspect before each use: check for broken stitches or parts; torn, cut or frayed material; or buckles that are cracked or broken and do not hold securely. Never use soiled or damaged products. " manufacturer reference file # (b)(4). Product not returned.
Patient Sequence No: 1, Text Type: N, H10
[60873727]
Customer reported while the gait belt was in use with a patient, who strongly depends on the belt, the belt began to rise. Customer believes it is possibly due to the teeth not having a strong connection into the material. Customer reported because the belt would not stabilize it began to rise causing the patient to fall. The date the incident occurred is unknown and no serious injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[63454302]
Lot number was added. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[63454303]
Supplemental mdr required for product evaluation results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2016-00048 |
| MDR Report Key | 6126400 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-11-23 |
| Date of Report | 2016-12-14 |
| Date Mfgr Received | 2016-12-14 |
| Device Manufacturer Date | 2013-06-27 |
| Date Added to Maude | 2016-11-23 |
| 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 | 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 |
| Manufacturer G1 | DONGGUAN POSEY MEDICAL DEVICE CO., LTD |
| Manufacturer Street | FUMIN ROAD, TANGLI VILLAGE FENGGANG TOWN |
| Manufacturer City | DONGGUAN / GUANGDONG, CHINA |
| Manufacturer Country | CH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SINGLE PATIENT USE GAIT BELT |
| Generic Name | AID, TRANSFER |
| Product Code | IKX |
| Date Received | 2016-11-23 |
| Model Number | 6556 |
| Catalog Number | 6556 |
| Lot Number | 3178D16 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POSEY COMPANY |
| Manufacturer Address | 5635 PECK ROAD ARCADIA CA 910060020 US 910060020 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-23 |