MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-05 for C-ARMOR 5523 manufactured by .
[110581502]
Bl (other)- product was requested to be returned and has not been received in for evaluation. Note: this report is based solely on the customer reported issue. At this time and without the return of the device the complaint cannot be confirmed. The instructions for use were reviewed and determined to provide adequate instructions for the safe and effective use of the device. A preventive action was initiated for awareness. 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).
Patient Sequence No: 1, Text Type: N, H10
[110581503]
Customer reported a hair was found in the c-arm drape while opening for a case. There were no serious injuries reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182318-2018-00002 |
| MDR Report Key | 7571671 |
| Date Received | 2018-06-05 |
| Date of Report | 2018-04-27 |
| Date of Event | 2018-04-25 |
| Date Mfgr Received | 2018-04-27 |
| Date Added to Maude | 2018-06-05 |
| 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 | KRIEGLSTEIN |
| Manufacturer Street | 570 ENTERPRISE DRIVE |
| Manufacturer City | NEENAH WI 54956 |
| Manufacturer Country | US |
| Manufacturer Postal | 54956 |
| Manufacturer Phone | 9207514300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | C-ARMOR |
| Generic Name | C-ARM EQUIPMENT COVERS |
| Product Code | PUI |
| Date Received | 2018-06-05 |
| Model Number | 5523 |
| Catalog Number | 5523 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-05 |