MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-02-27 for TOC PLS BCRB-INDIV 800 6075 manufactured by Sage Products Llc.
[139567560]
Reporter discarded the involved product and did not provide photographs or lot information. Due to the lack of lot information, a product history record could not be reviewed. Reporter stated approximately half of the green foam remained on the swab handle. This would indicate that the foam head was glued to the swab handle appropriately. Reporter stated the patient was (b)(6), and while unsupervised, bit down on the green foam causing it to disengage. Per 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. Children under 12 years of age should be supervised in the use of the product?. The root cause of the reported condition could be attributed to user error related to biting performed by the young unsupervised child.
Patient Sequence No: 1, Text Type: N, H10
[139567561]
Report received of foam disengagement due to biting. The reporter advised the product was in the house from a family member's recent hospital stay. Reporter stated the green swabs were not intended to be used on his son. Reporter stated on (b)(6) 2019, his son was unsupervised and opened the green swab thinking it was a lollipop. Reporter stated his son bit off the top half of the green foam and swallowed it. Reporter stated foam could not be located in his son's mouth and his son did not appear to be in any respiratory or gastrointestinal distress. Reporter stated the white stick remained intact with half of the un-bitten foam still adhered to the stick. Reporter stated his son was not injured and the green foam was found in his feces on (b)(6) 2019. The involved device was discarded and no photographs or lot information were available. Although requested, no additional information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001419181-2019-00002 |
| MDR Report Key | 8376519 |
| Report Source | CONSUMER |
| Date Received | 2019-02-27 |
| Date of Report | 2019-02-27 |
| Date of Event | 2019-01-30 |
| Date Mfgr Received | 2019-01-30 |
| Date Added to Maude | 2019-02-27 |
| 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-INDIV 800 |
| Generic Name | ORAL SWAB |
| Product Code | KXF |
| Date Received | 2019-02-27 |
| Model Number | 6075 |
| Catalog Number | 6075 |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| 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 | 2019-02-27 |