MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-08-24 for BLOM-SINGER SP 2113 manufactured by Freudenberg Medical, Llc.
[83649546]
This report was originally submitted on 10/25/2016, in an incorrect format. This was initially discovered on 8/23/2017, and this is being re-submitted on 8/24/2017.
Patient Sequence No: 1, Text Type: N, H10
[83649547]
Nasal septal device was placed in patient successfully. The physician decided a different size device was needed and began removing the device. The device was removed one side at a time. The left side was removed first, successfully. When the physician returned to remove the right side, the device fell back into the patient's throat and was subsequently swallowed. The device was confirmed to be in the esophagus through x-ray. The physician determined that the device will pass through the patient without further medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025182-2016-00006 |
| MDR Report Key | 6817182 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-08-24 |
| Date of Report | 2016-10-25 |
| Date of Event | 2016-10-06 |
| Date Mfgr Received | 2016-10-06 |
| Device Manufacturer Date | 2016-03-04 |
| Date Added to Maude | 2017-08-24 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. ALYSE MENCIAS |
| Manufacturer Street | 1110 MARK AVE |
| Manufacturer City | CARPINTERIA CA 93013 |
| Manufacturer Country | US |
| Manufacturer Postal | 93013 |
| Manufacturer Phone | 8055765414 |
| Manufacturer G1 | FREUDENBERG MEDICAL, LLC |
| Manufacturer Street | 1110 MARK AVE |
| Manufacturer City | CARPINTERIA CA 93013 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93013 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLOM-SINGER |
| Generic Name | NASAL SEPTAL BUTTON |
| Product Code | LFB |
| Date Received | 2017-08-24 |
| Catalog Number | SP 2113 |
| Lot Number | 0000025177 |
| Device Expiration Date | 2019-03-31 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FREUDENBERG MEDICAL, LLC |
| Manufacturer Address | 1110 MARK AVE CARPINTERIA CA 93013 US 93013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-08-24 |