MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2017-04-07 for APEX SUPERIOR ADHESIVE SLIDE WHITE 3800080E manufactured by Leica Biosystems Inc.
[72174299]
Investigation pending return of product from customer. If additional information is provided, a follow up report will be submitted. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[72174300]
Customer reported tissue was lost off the microscope slide during the staining process. Two patient samples were lost and required re-biopsy. Patient identifier was not provided. Actual date of event was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419341-2017-00001 |
| MDR Report Key | 6473081 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2017-04-07 |
| Date of Report | 2017-03-15 |
| Date Mfgr Received | 2017-03-15 |
| Device Manufacturer Date | 2016-07-31 |
| Date Added to Maude | 2017-04-07 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. JOAN MOYNIHAN |
| Manufacturer Street | 5205 US-12 |
| Manufacturer City | RICHMOND IL 60071 |
| Manufacturer Country | US |
| Manufacturer Postal | 60071 |
| Manufacturer Phone | 8156782000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APEX SUPERIOR ADHESIVE SLIDE WHITE |
| Generic Name | MICROSCOPE SLIDE |
| Product Code | KEW |
| Date Received | 2017-04-07 |
| Catalog Number | 3800080E |
| Lot Number | 4900040765 |
| Device Expiration Date | 2017-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS INC |
| Manufacturer Address | 5205 US-12 RICHMOND IL 60073 US 60073 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-07 |