MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-04 for SUB-X CLEARING AGENT 3803672 manufactured by Leica Biosystems Richmond.
[110038564]
Product retains currently being evaluated by manufacturer. An investigation is currently underway and a follow-up will be submitted should additional information become available following the investigation.
Patient Sequence No: 1, Text Type: N, H10
[110038565]
On (b)(6) 2018, four customer employees were exposed to chemical fumes while the product was in use in the customer's mobile unit. One of the four customer employees sought medical attention for a migraine. Symptoms were reported to have subsided by (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419341-2018-00002 |
| MDR Report Key | 7567358 |
| Date Received | 2018-06-04 |
| Date of Report | 2018-10-30 |
| Date of Event | 2018-05-04 |
| Date Mfgr Received | 2018-07-24 |
| Device Manufacturer Date | 2018-03-29 |
| Date Added to Maude | 2018-06-04 |
| 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 | MR. PETER SPARACIO |
| Manufacturer Street | 5205 RTE 12 |
| Manufacturer City | RICHMOND 60071 |
| Manufacturer Country | US |
| Manufacturer Postal | 60071 |
| Manufacturer Phone | 8156782000 |
| Manufacturer G1 | LEICA BIOSYSTEMS RICHMOND |
| Manufacturer Street | 5205 RTE 12 |
| Manufacturer City | RICHMOND IL 60071 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60071 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SUB-X CLEARING AGENT |
| Generic Name | SUB-X CLEARING AGENT |
| Product Code | KEM |
| Date Received | 2018-06-04 |
| Model Number | 3803672 |
| Lot Number | 030718 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS RICHMOND |
| Manufacturer Address | 5205 RTE 12 RICHMOND IL 60071 US 60071 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-04 |