MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-08-10 for ACTIVITY APRON II 7405 manufactured by Posey Products Llc.
[117151482]
Evaluation codes: customer confirmed the product was misplaced and will not returning. This event is reported solely on the information provided by the customer. The customer reported the patient caused the damage to the device and caused the beads to leak out. A historical review of the complaint database showed 2 other complaints where beads were leaking out of the apron due to loose stitching. Root cause for the loose stitching could not be determined and no patient injury was reported for either events. 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. The ifu states as a warning "patients may attempt to remove buttons and put them in their mouth. " it was also recommended to "inspect before each use: check for broken stitches; or torn, cut or frayed material. Do not use soiled or damaged products. " therefore, no corrective or preventive 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). Product had been discarded.
Patient Sequence No: 1, Text Type: N, H10
[117151483]
Customer reported her patient chewed through the orange doughnut shaped piece on the apron. This caused the small beads to scatter all over the room. The patient did not eat or inhale any beads. The date the issue was discovered is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2018-00069 |
| MDR Report Key | 7773085 |
| Report Source | USER FACILITY |
| Date Received | 2018-08-10 |
| Date of Report | 2018-07-20 |
| Date Mfgr Received | 2018-07-20 |
| Date Added to Maude | 2018-08-10 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACTIVITY APRON II |
| Generic Name | AID, TRANSFER |
| Product Code | IKX |
| Date Received | 2018-08-10 |
| Model Number | 7405 |
| Catalog Number | 7405 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POSEY PRODUCTS LLC |
| Manufacturer Address | 5635 PECK RD ARCADIA CA 91006 US 91006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-10 |