MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2011-12-02 for SKLAR manufactured by Sklar.
[2438730]
While inserting chest tube, the clamp was used to advance soft plastic tube into pleural cavity. Upon retrieval of clamp, it was noticed the jaw of device was missing (one side only). Pt taken emergently to operating room for removal of detached piece.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2444433 |
| MDR Report Key | 2444433 |
| Report Source | 99 |
| Date Received | 2011-12-02 |
| Date of Report | 2011-12-02 |
| Date of Event | 2011-11-30 |
| Date Facility Aware | 2011-11-30 |
| Report Date | 2011-12-02 |
| Date Reported to FDA | 2011-12-02 |
| Date Reported to Mfgr | 2011-12-02 |
| Date Added to Maude | 2012-02-10 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKLAR |
| Generic Name | HEMOSTAT |
| Product Code | HRQ |
| Date Received | 2011-12-02 |
| Returned To Mfg | 2011-12-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SKLAR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-12-02 |