MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-05 for STERILE TONGUE DEPRESSOR, 6" MDS202075 manufactured by Medline Industries, Inc..
[177795716]
Patient was undergoing a gyn surgical procedure. The intubation was difficult. 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 was lost in the patient's aerodigestive tract. An ent was consulted for removal while the patient was in the operation room. The foreign body was removed from the right nasopharynx. The patient was admitted for observation following the removal. The patient underwent further studies and the patient was diagnosed with a hypopharyngeal/pharyngeal perforation, confirmed free air in the neck, significant dysphagia and odynophagia, and contrast aspiration.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9670475 |
| MDR Report Key | 9670475 |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-01-31 |
| Report Date | 2020-02-03 |
| Date Reported to FDA | 2020-02-03 |
| Date Reported to Mfgr | 2020-02-05 |
| Date Added to Maude | 2020-02-05 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERILE TONGUE DEPRESSOR, 6" |
| Generic Name | DEPRESSOR, TONGUE, NON-SURGICAL |
| Product Code | FMA |
| Date Received | 2020-02-05 |
| Catalog Number | MDS202075 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2020-02-05 |