MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-06-08 for STERILE-Z BACK TABLE COVER 5575 manufactured by Tidi Products Llc.
[110586055]
Product was received for evaluation and the customer reported issue was confirmed. The device was received in its original packaging and was not opened. Inside the packaging, a dark color strand of hair was identified. The device is being further investigated to determined the root cause of the failure. Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device. 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
[110586056]
Customer reported one of the samples appears to have a hair inside of the sterile packaging. The date the issue was discovered is not known. No serious injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182318-2018-00003 |
| MDR Report Key | 7583732 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-06-08 |
| Date of Report | 2018-05-15 |
| Date Mfgr Received | 2018-05-15 |
| Date Added to Maude | 2018-06-08 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | STERILE-Z BACK TABLE COVER |
| Generic Name | STERILE-Z BACK TABLE COVER |
| Product Code | PUI |
| Date Received | 2018-06-08 |
| Returned To Mfg | 2018-06-04 |
| Model Number | 5575 |
| Catalog Number | 5575 |
| Lot Number | 1105180714 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TIDI PRODUCTS LLC |
| Manufacturer Address | 570 ENTERPRISE DR NEENAH WI 54956 US 54956 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-08 |