MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-10-25 for FORSUS FATIGUE RESISTANT DEVICE PUSH ROD XS 885-010 manufactured by 3m Unitek.
[2222191]
Adult patient swallowed a 22mm orthodontic push rod. Patient went to the emergency room and had an x-ray. There was no damage, but doctor decided it would be best to intervene, so an endoscope down the throat was used to retrieve the swallowed device. Patient is fine and is continuing her orthodontic treatment.
Patient Sequence No: 1, Text Type: D, B5
[9371717]
Unable to determine why the device came apart to the point that the push rod detached and patient swallowed it. Orthodontic assistant stated she had no prior experience with that happening in any other cases using this device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020467-2011-00003 |
| MDR Report Key | 2314381 |
| Report Source | 07 |
| Date Received | 2011-10-25 |
| Date of Report | 2011-10-28 |
| Date of Event | 2011-10-07 |
| Date Mfgr Received | 2011-10-13 |
| Date Added to Maude | 2011-11-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS KATHLEEN BACON |
| Manufacturer Street | 2724 SOUTH PECK RD. |
| Manufacturer City | MONROVIA CA 910165097 |
| Manufacturer Country | US |
| Manufacturer Postal | 910165097 |
| Manufacturer Phone | 6265744212 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FORSUS FATIGUE RESISTANT DEVICE PUSH ROD XS |
| Generic Name | SPRING, ORTHODONTIC, PRODUCT CODE ECO |
| Product Code | ECO |
| Date Received | 2011-10-25 |
| Model Number | 885-010 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M UNITEK |
| Manufacturer Address | MONROVIA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-10-25 |