MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-11-28 for LEICA BIOSYSTEMS manufactured by Leica Biosystems Nussloch.
[128665958]
Complaint data was reviewed from january 1st, 2017 to november 27th, 2018 and no other complaints were identified for this product lot that reported an issue with the dispenser. Product retains are currently being evaluated by the 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
[128665959]
Customer's employee was attempting to dispense the disposable blades (lot 118253) and when it would not dispense the product, the customer attempted to pull the product from the dispenser. Once the attempt was executed, the employee experienced a cut on the finger and required emergency room medical attention in the form of stitches. Incident occured on (b)(6) 2018 and was reported to leica biosystems (b)(4) 2018. Additional information was required and was provided to leica biosystems (b)(6) 2018. Complaint record was created 11/09/2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419341-2018-00004 |
| MDR Report Key | 8112433 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-11-28 |
| Date of Report | 2019-01-25 |
| Date of Event | 2018-09-10 |
| Date Mfgr Received | 2019-01-11 |
| Device Manufacturer Date | 2018-06-20 |
| Date Added to Maude | 2018-11-28 |
| 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 | MR. PETER SPARACIO |
| Manufacturer Street | 5205 US HIGHWAY 12 |
| Manufacturer City | RICHMOND IL 60071 |
| Manufacturer Country | US |
| Manufacturer Postal | 60071 |
| Manufacturer G1 | LEICA BIOSYSTEMS NUSSLOCH |
| Manufacturer Street | HEIDELBERGER STRABE 17-19 |
| Manufacturer City | NUSSLOCH, 69226 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 69226 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEICA BIOSYSTEMS |
| Generic Name | LOW-PROFILE DISPOSABLE BLADES DB80LS (10X50) |
| Product Code | IDL |
| Date Received | 2018-11-28 |
| Returned To Mfg | 2018-12-17 |
| Lot Number | 118253 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS NUSSLOCH |
| Manufacturer Address | HEIDELBERGER STRABE 17-19 NUSSLOCH, 69226 GM 69226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-11-28 |