MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-22 for LYOPLANT manufactured by Aesculap, Inc.
[176234315]
Patient underwent chiari decompression with use of lyoplant graft on (b)(6) 2020, returned to hospital with aseptic meningitis on (b)(6) 2020. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092427 |
| MDR Report Key | 9622007 |
| Date Received | 2020-01-22 |
| Date of Report | 2020-01-20 |
| Date of Event | 2020-01-02 |
| Date Added to Maude | 2020-01-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LYOPLANT |
| Generic Name | DURA SUBSTITUTE |
| Product Code | GXQ |
| Date Received | 2020-01-22 |
| Lot Number | 219445 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP, INC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-01-22 |