MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-07-19 for TOC PLS BCRB-20PK 1000 N/A 6076 manufactured by Sage Products Llc.
[114589229]
Reporter discarded the involved product and did not provide photographs or lot information. Production history records could not be reviewed. Per the packaging instructions it states,? Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands?. Without further information, biting of the swab cannot be ruled out. The root cause could not be determined due to insufficient information. Without further information, there is insufficient evidence to conclude that the reported issue could be attributable to a product defect or manufacturing operations.
Patient Sequence No: 1, Text Type: N, H10
[114589230]
Report received of an applicator swab foam disengagement. On (b)(6) 2018, a distributor received a report that foam fell off the top of the applicator swab and lodged in the patient? S throat. The distributor's report states a home health nurse was able to suction out the disengaged foam. The distributor report states no injury occurred. Multiple attempts to obtain further information were unsuccessful. The distributor reported that the involved product was not returned. Although requested, no additional information was available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001419181-2018-00024 |
| MDR Report Key | 7703929 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-07-19 |
| Date of Report | 2018-07-19 |
| Date of Event | 2018-06-21 |
| Date Mfgr Received | 2018-06-22 |
| Date Added to Maude | 2018-07-19 |
| 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 | MR. 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 | TOC PLS BCRB-20PK 1000 |
| Generic Name | TOOTHETTE? ORAL CARE DISPOSABLE ORAL SWAB |
| Product Code | KXF |
| Date Received | 2018-07-19 |
| Model Number | N/A |
| Catalog Number | 6076 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-07-19 |