MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-01 for MDS202000 manufactured by Medline Industries.
[69019457]
A cotton tipped applicator broke and a patient swallowed a piece. The patient was having a strep test performed. As the physician was swabbing the patient's throat the wooden stick broke. The patient ingested approximately a? Inch piece including the cotton tip. An abdominal x-ray and esophagram showed the swallowed piece had passed through the jejunum. Follow up showed the patient to be passing urine and stools; patient's abdomen was soft and non-tender with no apparent signs of bowel obstruction. A sample was not returned. A root cause cannot be determined but user error may be a contributing factor. Due to the reported incident and in an abundance of caution this medwatch is being filed. Not returned.
Patient Sequence No: 1, Text Type: N, H10
[69019458]
It was reported cotton tipped applicator broke in a patient's mouth and was ingested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2017-00007 |
| MDR Report Key | 6368764 |
| Date Received | 2017-03-01 |
| Date of Report | 2017-03-01 |
| Date of Event | 2016-01-31 |
| Date Mfgr Received | 2017-01-31 |
| Device Manufacturer Date | 2016-01-01 |
| Date Added to Maude | 2017-03-01 |
| 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. MEGAN DEBUS |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 8477703962 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | COTTON TIP APPLICATOR |
| Product Code | KXG |
| Date Received | 2017-03-01 |
| Catalog Number | MDS202000 |
| Lot Number | 01016010003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-01 |