MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-17 for PROCARE ONE-PIECE CERVICAL COLLAR 79-83131 manufactured by Djo, Llc.
[145615396]
On multiple occasions, the product (procare black one-piece cervical collar - 79-83131) broke while it was being sized / applied to the pt while being used / applied in accordance with mfr's instructions. Generally, the break occurs in the area where the collar fits under the chin (grey plastic in pictures). At one time, a small piece of hard plastic broke off. Flew through the air, and just narrowly missed hitting someone in the face. People applying this collar seem to experience a >50% failure / breakage rate. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086721 |
| MDR Report Key | 8623742 |
| Date Received | 2019-05-17 |
| Date of Report | 2019-05-16 |
| Date of Event | 2019-05-14 |
| Date Added to Maude | 2019-05-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | PROCARE ONE-PIECE CERVICAL COLLAR |
| Generic Name | ORTHOSIS, CERVICAL |
| Product Code | IQK |
| Date Received | 2019-05-17 |
| Catalog Number | 79-83131 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-17 |