MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-08-17 for C-ARMOR 5536 manufactured by Tidi Products, Llc.
[117588969]
Affected product was not returned to the manufacturer. However, photographs were provided and manufacturer was able to confirm the contamination of the product in its packaging. At this time, the investigation is ongoing, and no further information is available. Manufacturer reference file: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[117589010]
Customer reported a foreign material, possibly a bug, was found inside the sealed and sterile package of a drape cover. No further information was provided. 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 | 2182318-2018-00005 |
| MDR Report Key | 7795162 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-08-17 |
| Date of Report | 2018-07-19 |
| Date Mfgr Received | 2018-07-19 |
| Device Manufacturer Date | 2017-08-04 |
| Date Added to Maude | 2018-08-17 |
| 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 | 9207514300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | C-ARMOR |
| Generic Name | C-ARMOR DRAPE KIT |
| Product Code | PUI |
| Date Received | 2018-08-17 |
| Model Number | 5536 |
| Catalog Number | 5536 |
| Lot Number | 018301 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TIDI PRODUCTS, LLC |
| Manufacturer Address | 570 ENTERPRISE DRIVE NEENAH WI 54956 US 54956 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-17 |