MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-08-22 for C-ARMOR 5523 manufactured by .
[118093586]
Affected product was returned and manufacturer was able to confirm the reported foreign material in the product. Inspection of the material determine it is non-biological in origin. At this time, the investigation is ongoing and no further information is available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[118093587]
Customer detected foreign contaminant in sterile drape while prepping the patient. The date the issue was discovered is unknown and no patient incident or injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182318-2018-00006 |
| MDR Report Key | 7807731 |
| Report Source | CONSUMER |
| Date Received | 2018-08-22 |
| Date of Report | 2018-07-27 |
| Date Mfgr Received | 2018-07-27 |
| Device Manufacturer Date | 2017-12-22 |
| Date Added to Maude | 2018-08-22 |
| 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 | JACKIE KRIEGLSTEIN |
| Manufacturer Street | 570 ENTERPRISE DRIVE |
| Manufacturer City | NEENAH WI 54956 |
| Manufacturer Country | US |
| Manufacturer Postal | 54956 |
| Manufacturer Phone | 9207517300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | C-ARMOR |
| Generic Name | C-ARMOR DRAPE |
| Product Code | PUI |
| Date Received | 2018-08-22 |
| Returned To Mfg | 2018-08-13 |
| Model Number | 5523 |
| Lot Number | 019269 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-22 |