MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-12-12 for TRANSFER BELT, QUICK-RELEASE ECONOMY 6537Q manufactured by J.t. Posey Company.
[62183682]
Product was requested to be returned for evaluation and has not been received. Note: this report is based solely on the customer reported issue. Note: 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). Device not yet received.
Patient Sequence No: 1, Text Type: N, H10
[62183683]
Customer reported that while using the belt to try and lift the patient, the material of the belt ripped in half and the caregiver fell. The fall caused a compression fracture that will take up to 3 months to heal.
Patient Sequence No: 1, Text Type: D, B5
[65786520]
Fields were updated with new information. Product was requested to be returned and has not yet been received. The customer reported additional facts about the reported incident. Customer reported to have suffered compression fractures to her back in the accident on (b)(6) 2016 when her transfer belt allegedly separated at the stitching while she was attempting to lift her (b)(6) year old husband out of his chair. Customer reported the belt separated, not at the handles or at the buckle, but at the point where two layers of material were joined. The product has been requested to be returned but has not yet been received. Manufacturer reference file # (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[65786521]
A supplemental medwatch is required for additional event information.
Patient Sequence No: 1, Text Type: D, B5
[69330731]
Evaluation of the returned device found the webbing of the belt has been cut and separated into two pieces. The cut to the webbing appears to have been made with a sharp instrument since the nylon fibers of the black webbing are uniformly lined up and the webbing does not show signs of tensile failure. All (b)(6) green nylon handles are present and intact. The product dimensions are within specification (excluding the cut area). Both the male and female ends of the quick release buckle are present, intact and the buckle is fully functional. Based on the nature of the damage and the available evidence, it appears the belt may have been intentionally cut. At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint as it appears the belt. Therefore, no corrective or preventative actions are necessary. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[69330732]
Supplemental medwatch required for product evaluation results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2016-00049 |
| MDR Report Key | 6168320 |
| Report Source | CONSUMER |
| Date Received | 2016-12-12 |
| Date of Report | 2017-02-08 |
| Date of Event | 2016-11-07 |
| Date Mfgr Received | 2017-02-08 |
| Device Manufacturer Date | 2016-05-12 |
| Date Added to Maude | 2016-12-12 |
| 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 FAMILY MEMBER OR FRIEND |
| 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 | POSEY, S. DE R.L. DE C.V. |
| Manufacturer Street | AVE. FERROCARRIL NO. 16901. BO COLONIA RIO TIJUANA, 3RA. ETAP |
| Manufacturer City | TIJUANA, MEXICO |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSFER BELT, QUICK-RELEASE ECONOMY |
| Generic Name | AID, TRANSFER |
| Product Code | IKX |
| Date Received | 2016-12-12 |
| Returned To Mfg | 2017-02-06 |
| Model Number | 6537Q |
| Catalog Number | 6537Q |
| Lot Number | 6132T075 |
| ID Number | NA |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | J.T. POSEY COMPANY |
| Manufacturer Address | 5635 PECK ROAD ARCADIA CA 910060020 US 910060020 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2016-12-12 |