MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-03 for PEDI-WRAP PEDI-WRAPS manufactured by Medi-kid Co..
[25342471]
Medi-kid co. , sells a product called pedi-wraps which are arm immobilizers for kids after surgery to keep the kids' arms straight so that they can't damage a newly repaired lip or palate. I understand this is a class 1 device and is exempt from being approved. However, they sell a shoulder strap that attaches to the top of each immobilizer and wrap behind the child's neck. They include these to help keep the immobilizers from slipping off the child's arm. This strap is approx 14" long. This strap is not exempt per your guidelines and is a serious strangulation hazard. I feel like this is death waiting to happen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5056029 |
| MDR Report Key | 5064100 |
| Date Received | 2015-09-03 |
| Date of Report | 2015-09-03 |
| Date of Event | 2015-09-01 |
| Date Added to Maude | 2015-09-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PEDI-WRAP |
| Generic Name | PEDI-WRAP |
| Product Code | NOC |
| Date Received | 2015-09-03 |
| Model Number | PEDI-WRAPS |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDI-KID CO. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2015-09-03 |