MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-03-05 for CARBON STEEL BLADE MDS15010L manufactured by Medline Industries, Inc..
[4298769]
The blade broke and fell into the surgical site. It was retrieved without injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
[11551734]
The blade broke and fell into the surgical site. It was retrieved without injury to the patient and no further intervention was required. The piece was returned and the issue was confirmed. The break across the blade was clean and straight. A root cause was not determined for this incident. We have no trend for this issue with this device. It is not known if user error may have played a role.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00024 |
| MDR Report Key | 3674390 |
| Report Source | 06 |
| Date Received | 2014-03-05 |
| Date of Report | 2014-02-28 |
| Date of Event | 2014-01-30 |
| Date Mfgr Received | 2014-01-31 |
| Date Added to Maude | 2014-03-13 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JULIE FINLEY |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARBON STEEL BLADE |
| Product Code | GDX |
| Date Received | 2014-03-05 |
| Catalog Number | MDS15010L |
| Lot Number | MO2388 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-03-05 |