MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-06 for TRANSFER BELT, QUICK-RELEASE ECONOMY 6537Q manufactured by Posey Products Llc.
[85758323]
This report is based solely on a product review and no incidents were reported. If the belt slides or the buckle loosens, it may allow the unintentional release of the patient. The instructions for use were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device. The application instructions caution the user to 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 nonconformity 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. Therefore, no corrective or preventative actions are necessary at this time. (b)(4). Device not available. Customer review.
Patient Sequence No: 1, Text Type: N, H10
[85758324]
Post market surveillance search on (b)(6) found a review that the posey transfer belt slides when in use and the buckle becomes loose fast. The date the issue was discovered is unknown and no incident were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2017-00063 |
| MDR Report Key | 6845156 |
| Date Received | 2017-09-06 |
| Date of Report | 2017-08-14 |
| Date Mfgr Received | 2017-08-14 |
| Date Added to Maude | 2017-09-06 |
| 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 | WILLIAM HINCY |
| Manufacturer Street | POSEY PRODUCTS LLC 5635 PECK ROAD |
| Manufacturer City | ARCADIA CA 91006 |
| Manufacturer Country | US |
| Manufacturer Postal | 91006 |
| Manufacturer Phone | 6264433143 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TRANSFER BELT, QUICK-RELEASE ECONOMY |
| Generic Name | AID, TRANSFER |
| Product Code | IKX |
| Date Received | 2017-09-06 |
| Model Number | 6537Q |
| Catalog Number | 6537Q |
| Lot Number | UNK |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POSEY PRODUCTS LLC |
| Manufacturer Address | 5635 PECK ROAD ARCADIA CA 91006 US 91006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-06 |