MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-02-27 for REF MD5096513 1--80196802104 REF MDSO96513 manufactured by Medline Industries Inc.
[3174923]
Oral care sponge broke off in pt's mouth during routine oral care. The head of the oral care sponge noted to snap off. Device failure created an unsafe condition. Dates of use: (b)(6) 2013 - (b)(6) 2013. Event abated after use stopped: yes. Event reappeared after reintroduction: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5029226 |
| MDR Report Key | 2993991 |
| Date Received | 2013-02-27 |
| Date of Report | 2013-02-27 |
| Date of Event | 2013-01-25 |
| Date Added to Maude | 2013-03-11 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REF MD5096513 |
| Generic Name | SUCTION SWAB KIT |
| Product Code | EHZ |
| Date Received | 2013-02-27 |
| Model Number | 1--80196802104 |
| Catalog Number | REF MDSO96513 |
| Lot Number | 12353 |
| Device Expiration Date | 2014-07-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC |
| Manufacturer Address | MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-02-27 |