MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-01 for CODMAN NEURO SPONGES manufactured by Codman And Shurtleff Neuro Sponges.
[90941787]
The operating room crew were counting during set up of a procedure and found that when counting there were 11 neuro sponges in the pack instead of 10. This was found prior to a patient being brought into the operating room. Operating room had saved the sponges but since that time they have been unable to locate them. Therefore the sponges are not available for return.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073064 |
| MDR Report Key | 6993474 |
| Date Received | 2017-11-01 |
| Date of Report | 2017-10-11 |
| Date of Event | 2017-09-27 |
| Date Added to Maude | 2017-11-01 |
| 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 | 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 | 0 |
| Brand Name | CODMAN NEURO SPONGES |
| Generic Name | NEURO SPONGES |
| Product Code | GEL |
| Date Received | 2017-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN AND SHURTLEFF NEURO SPONGES |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-01 |