MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-24 for MEDLINE NEURO SPONGES NEUROSPNG09 manufactured by Medline Industries, Inc..
[176665882]
Neuro sponge sterile pack found to have gum inside of pack, compromising the sterility of that pack and all packs associated with that lot in our inventory. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092504 |
| MDR Report Key | 9632194 |
| Date Received | 2020-01-24 |
| Date of Report | 2020-01-22 |
| Date of Event | 2020-01-17 |
| Date Added to Maude | 2020-01-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | MEDLINE NEURO SPONGES |
| Generic Name | NEUROSURGICAL PADDLE |
| Product Code | HBA |
| Date Received | 2020-01-24 |
| Catalog Number | NEUROSPNG09 |
| Lot Number | 6051908102 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-24 |