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 2018-06-29 for SECURESLEEVE, INFANT 8168I manufactured by Posey Products Llc.
[112719693]
Product is scheduled to be returned but have not been received in by manufacturing at the time of this report. Therefore, this report is based solely on the information provided by the customer. At this time there is not 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 warning for safe and effective use of the device. 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). No product returned at this time.
Patient Sequence No: 1, Text Type: N, H10
[112719694]
Customer reported while in use with the secure sleeve the patient was able to remove a tube, possibly a nasogastric tube. The date the issue was discovered is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2018-00048 |
| MDR Report Key | 7650078 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-06-29 |
| Date of Report | 2018-07-25 |
| Date Mfgr Received | 2018-07-25 |
| Date Added to Maude | 2018-06-29 |
| 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 | SECURESLEEVE, INFANT |
| Generic Name | SPLINT, EXTREMITY, NON-INFLATABLE, EXTERNAL, NON-STERILE |
| Product Code | NOC |
| Date Received | 2018-06-29 |
| Model Number | 8168I |
| Catalog Number | 8168I |
| Lot Number | UNK |
| Operator | NURSE |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POSEY PRODUCTS LLC |
| Manufacturer Address | 5635 PECK ROAD ARCADIA 91006 US 91006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-06-29 |