MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-05 for DEVICE PACK manufactured by Medline Industries.
[123371859]
There was a dead spider found in the fold of half drape that was in our device pack (ep lab). The sheet was not used in the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080410 |
| MDR Report Key | 7946884 |
| Date Received | 2018-10-05 |
| Date of Report | 2018-09-11 |
| Date of Event | 2018-08-21 |
| Date Added to Maude | 2018-10-09 |
| 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 | 0 |
| Brand Name | DEVICE PACK |
| Generic Name | TRAY, SURGICAL |
| Product Code | LRP |
| Date Received | 2018-10-05 |
| Lot Number | 18DD0801 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES |
| Brand Name | DEVICE PACK |
| Generic Name | TRAY, SURGICAL |
| Product Code | LRP |
| Date Received | 2018-10-05 |
| Lot Number | 18DD0801 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-05 |