MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-07-27 for LEICA M530 OH6 manufactured by Leica Microsystems (schweiz) Ag.
[115189720]
(b)(4). An investigation of the incident is currently underway and a follow-up will be submitted should additional information become available following investigation.
Patient Sequence No: 1, Text Type: N, H10
[115189721]
On (b)(6) 2018, leica microsystems ((b)(6)) ag received a complaint from the (b)(6) stating that three (3) patients had skin ulcerations and one (1) patient had thermal burn immediately following surgery. For this report one patient had skin ulceration immediately following surgery. See manufacturer/importer report numbers: 3003974370-2018-00007 / 3003974370-2018-00008 / 3003974370-2018-00010 for information regarding the other three (3) patients reported in the complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003974370-2018-00009 |
| MDR Report Key | 7725441 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-07-27 |
| Date of Report | 2018-09-10 |
| Date of Event | 2018-03-05 |
| Date Facility Aware | 2018-07-02 |
| Date Mfgr Received | 2018-07-02 |
| Device Manufacturer Date | 2017-08-14 |
| Date Added to Maude | 2018-07-27 |
| 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. ROLAND JEHLE |
| Manufacturer Street | MAX-SCHMIDHEINY-STRASSE 201 |
| Manufacturer City | HEERBRUGG, SANKT GALLEN 9435 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 9435 |
| Manufacturer G1 | LEICA INSTRUMENTS (SINGAPORE) PTE LTD |
| Manufacturer Street | 12 TEBAN GARDENS CRESCENT |
| Manufacturer City | SINGAPORE, SINGAPORE 608924 |
| Manufacturer Country | SN |
| Manufacturer Postal Code | 608924 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEICA M530 OH6 |
| Generic Name | SURGIAL MICROSCOPE |
| Product Code | EPT |
| Date Received | 2018-07-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 11 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA MICROSYSTEMS (SCHWEIZ) AG |
| Manufacturer Address | MAX-SCHMIDHEINY-STRASSE 201 HEERBRUGG, SANKT GALLEN 9435 SZ 9435 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-07-27 |