MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-09 for NEURAY? PACKING 8004000 manufactured by Xomed Mfg Mystic.
[179259474]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[179259475]
A health care provider (hcp) reported that on a arthroplasty. A device's patties were coming off of the strings. There was no patient impact. Upon follow up it was confirmed that patties were used on a patient during an arthroplasty. It was during the procedure when the rn identified that the patties were coming off of the strings. Here was no impact to patient or staff because this problem was identified during the procedure. His product was discarded during the case due to it being contaminated with blood.
Patient Sequence No: 1, Text Type: D, B5
[183603307]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183603308]
The event was reported to medwatch but the report number was unknown. There was no delay in the surgical procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219071-2020-00001 |
| MDR Report Key | 9568144 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-09 |
| Date of Report | 2020-02-19 |
| Date of Event | 2019-12-19 |
| Date Mfgr Received | 2020-02-04 |
| Device Manufacturer Date | 2017-10-01 |
| Date Added to Maude | 2020-01-09 |
| 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 | CHRISTY CAIN |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328353 |
| Manufacturer G1 | XOMED MFG MYSTIC |
| Manufacturer Street | 950 FLANDERS RD |
| Manufacturer City | MYSTIC CT 06355 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06355 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEURAY? PACKING |
| Generic Name | NEUROSURGICAL PADDIE |
| Product Code | HBA |
| Date Received | 2020-01-09 |
| Model Number | 8004000 |
| Catalog Number | 8004000 |
| Lot Number | 00030431 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XOMED MFG MYSTIC |
| Manufacturer Address | 950 FLANDERS RD MYSTIC CT 06355 US 06355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-09 |