MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-26 for SKLAR REPLACEMENT SLEEVE SILICON GUARD 75-1025 manufactured by Sklar Corporation.
[137461149]
While in pacu after almost 40 minutes patient sat up and began coughing then spit out an approx. 1cm pliable round clear plastic cylinder. Anesthesia and surgeons called to the bedside and unable to recognize origin of plastic piece. Operating room (or) charged rn to the bedside and called stryker rep. Who identified the piece as the protector on the end of the mouth guard/mouth retractor used intraoperatively. Sklar instruments (b)(4) us.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084421 |
| MDR Report Key | 8374227 |
| Date Received | 2019-02-26 |
| Date of Report | 2019-02-22 |
| Date of Event | 2019-02-15 |
| Date Added to Maude | 2019-02-27 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | SKLAR REPLACEMENT SLEEVE SILICON GUARD |
| Generic Name | CANNULA, SURGICAL, GENERAL AND PLASTIC SURGERY |
| Product Code | KBN |
| Date Received | 2019-02-26 |
| Model Number | 75-1025 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SKLAR CORPORATION |
| Brand Name | SKLAR REPLACEMENT SLEEVE SILICON GUARD |
| Generic Name | CANNULA, SURGICAL, GENERAL AND PLASTIC SURGERY |
| Product Code | GEA |
| Date Received | 2019-02-26 |
| Model Number | 75-1025 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER LEIBINGER GMBH AND CO. KG AM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-26 |