MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-09 for MDS202075 manufactured by Medline Industries Inc..
[186543348]
It was reported that the end user was under general anesthesia and the crna used a tongue depressor to assist with placement, when the distal tip of the tongue depressor broke off. The crna stated no excessive force was applied and the tongue depressor wood was cut across the grain, allowing the tongue depressor to "easily break" and pieces of the tongue depressor fell into the end users oropharynx. It was reported that "unsuccessful attempts" were made with forceps to retrieve the broken piece. The crna stated a piece went into the end users nasopharynx. A ent was brought in to retrieve the piece of the tongue depressor out of the right nare using video fluoroscopy. The end user was kept under anesthesia longer, due to the incident. The end user's physician ordered a swallow test, which showed a small esophageal tear, requiring the end user to remain npo and hospitalized for three days. It was reported the end user has fully recovered, since the incident. No additional information is available. The device was not returned to the manufacturer for evaluation. The customer reported issue was not confirmed. No additional information is available. Due to the reported incident, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[186543349]
The certified registered nurse anesthetist (crna) used a tongue depressor to expose the base of the tongue and the distal tip of the tongue depressor broke off and caused an esophageal tear.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2020-00025 |
| MDR Report Key | 9808118 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-01-13 |
| Date Mfgr Received | 2020-02-12 |
| Date Added to Maude | 2020-03-09 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KAREN TRUTSCH |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD, IL |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | BLADE, TONGUE, 6", STERILE |
| Product Code | FMA |
| Date Received | 2020-03-09 |
| Catalog Number | MDS202075 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD, IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-09 |