MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-03 for 89-6137.02 manufactured by Geo-med.
[22947725]
Upon opening a package for a minor abdominal tray distributed by geo-med, llc, (b)(4), lot 39072706, expiration date 06/202018, staff noted that a sterile towel had several dark colored spots that were approx 1 mm in size clearly visible on the towel. This is a custom package made for (b)(6). The pack was replaced and no harm to the pt or delay in pt care was experienced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5055296 |
| MDR Report Key | 4994477 |
| Date Received | 2015-08-03 |
| Date of Report | 2015-08-03 |
| Date of Event | 2015-07-30 |
| Device Manufacturer Date | 2014-12-01 |
| Date Added to Maude | 2015-08-12 |
| 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 |
| 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 |
| Generic Name | MINOR ABDOMINAL TRAY |
| Product Code | LRP |
| Date Received | 2015-08-03 |
| Model Number | 89-6137.02 |
| Catalog Number | 89-6137.02 |
| Lot Number | 39072706 |
| Device Expiration Date | 2019-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GEO-MED |
| Manufacturer Address | ALTAMONTE SPRINGS FL 32701 US 32701 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-03 |