MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-05-18 for 90 ML PREFILLED PJ 3800780 manufactured by Leica Biosystems Richmond.
[108667882]
An investigation of the incident 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
[108667883]
On (b)(6) 2018, product was received by customer materials management department and arrived leaking and damaged. Outer case packaging was reported to be dry while the inner case packaging was reported to be wet from leakage. Customer employee who opened the outer case packaging was exposed to formalin fumes and sought medical attention for respiratory problems. No follow up medical attention was required, employee was released the same day. Product was disposed by the carrier.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419341-2018-00001 |
| MDR Report Key | 7526550 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-05-18 |
| Date of Report | 2019-01-02 |
| Date of Event | 2018-04-13 |
| Date Mfgr Received | 2018-12-03 |
| Device Manufacturer Date | 2018-02-27 |
| Date Added to Maude | 2018-05-18 |
| 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 IL 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 | 3 |
| Brand Name | 90 ML PREFILLED PJ |
| Generic Name | 90 ML PREFILLED PJS |
| Product Code | IFP |
| Date Received | 2018-05-18 |
| Model Number | 3800780 |
| Lot Number | 022720 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-05-18 |