MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2017-06-02 for TOOTHETTE? ORAL CARE 6070-X, 6075-X, OR 6013-X manufactured by Sage Products Llc.
[76540401]
Reporter indicated photographs are available, however, multiple attempts to obtain photographs thus far have been unsuccessful.
Patient Sequence No: 1, Text Type: N, H10
[76540402]
The patient was admitted to the hospital from a nursing home with suspected aspiration pneumonia. The patient reportedly aspirated pieces of green foam. The manufacturer is attempting to gather more details on the reported issue.
Patient Sequence No: 1, Text Type: D, B5
[113411664]
The reporter discarded the involved product. Evaluation of the product could not be performed because no product code or lot number was made available. Although the initial medwatch report indicated photographs were available, the reporter subsequently clarified he did not have photographs of the involved product. The investigation focused on codes that could potentially be used in a nursing home setting. In-process quality checks are performed every one (1) hour for straw placement, glue coverage, and swab head pull test, however, product history reports (phrs) and product service requests (psrs) could not be evaluated as no product code or lot information for the affected product was known. Per the packaging instructions for all the potential products it states, "do not allow the patient to bite down on swab. " without further information, biting of the swab cannot be ruled out. Potential biting of the swab is further evident by the fact that the customer stated that green foam pieces were found in the patient's bronchial secretions. This could be caused by biting and chewing the foam. The root cause(s) of the reported condition could not be determined at this time. Potential root cause could be due to the patient potentially biting the swab. Discarded by facility.
Patient Sequence No: 1, Text Type: N, H10
[113411665]
Patient admitted to hospital from nursing home with suspected pneumonia. Reporter stated the patient was confused and unable to follow commands. Reporter stated green foam pieces were found in the patient's bronchial secretions and it was assumed the patient aspirated on pieces of foam from a sage swab prior to admission to the hospital. Reporter stated patient diagnosed with aspiration pneumonia, however, did not know the medical intervention performed on the patient. Reporter did not know if biting occurred, if the device was reused, or who performed oral care on the patient during use. Reporter did not have medical history and did not know the weight of the patient. Reporter did not have the involved product and did not have photographs available of the involved product. Reporter did not know the product code and did not have lot information. Although requested, no additional information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419181-2017-00004 |
| MDR Report Key | 6608174 |
| Report Source | FOREIGN |
| Date Received | 2017-06-02 |
| Date of Report | 2017-06-30 |
| Date of Event | 2017-03-14 |
| Date Mfgr Received | 2017-05-16 |
| Date Added to Maude | 2017-06-02 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. HEATHER SIRIANNI |
| Manufacturer Street | 3909 THREE OAKS ROAD |
| Manufacturer City | CARY IL 60013 |
| Manufacturer Country | US |
| Manufacturer Postal | 60013 |
| Manufacturer Phone | 8154554700 |
| Manufacturer G1 | SAGE PRODUCTS LLC |
| Manufacturer Street | 3909 THREE OAKS ROAD |
| Manufacturer City | CARY IL 60013 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60013 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOOTHETTE? ORAL CARE |
| Generic Name | ORAL SWAB |
| Product Code | KXF |
| Date Received | 2017-06-02 |
| Model Number | 6070-X, 6075-X, OR 6013-X |
| Catalog Number | 6070-X, 6075-X, OR 6013-X |
| Lot Number | UNKNOWN |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SAGE PRODUCTS LLC |
| Manufacturer Address | 3909 THREE OAKS ROAD CARY IL 60013 US 60013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2017-06-02 |