MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-02-07 for DEFOGGER 28-0101B manufactured by Deroyal Industries, Inc..
[136298168]
Investigation summary: an internal complaint (b)(4) was received indicating that the x-ray element separated from the anti-fog foam pad (finished good 28-0101b) during a procedure. The x-ray detectable strip fell into the patient but was located after detaching. There was no patient injury. A sample was unavailable to return for evaluation. The complaint investigator reviewed the work order for the reported lot number (48028715). There were 27 defects from this lot; however, these parts were rejected due to issues with the paper backing, which is unrelated to the reported event. No discrepancies were identified in the work order that could have contributed to the reported failure. No change has been made to the raw materials or the converting process for the anti-fog pad. The investigation is ongoing at this time. When new and critical information is available, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[136298169]
The x-ray detectable strip came off the anti-fog pad during a procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1060680-2019-00001 |
| MDR Report Key | 8317853 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-02-07 |
| Date of Report | 2019-02-27 |
| Date of Event | 2019-01-11 |
| Date Mfgr Received | 2019-01-11 |
| Date Added to Maude | 2019-02-07 |
| 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 | SARAH BENNETT |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653626112 |
| Manufacturer G1 | DEROYAL INDUSTRIES, INC. |
| Manufacturer Street | 1703 HIGHWWAY 33 SOUTH |
| Manufacturer City | NEW TAZEWELL TN 37825 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37825 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEFOGGER |
| Generic Name | ANTI-FOG SOLUTION |
| Product Code | OCT |
| Date Received | 2019-02-07 |
| Model Number | 28-0101B |
| Lot Number | 48028715 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | 185 RICHARDSON WAY MAYNARDVILLE TN 37807 US 37807 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-07 |