MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-02-06 for BLOM-SINGER ADJUSTABLE BI-FLANGED FISTULA FM1004 manufactured by Helix Medical, Llc.
[5352687]
The physician reported that the stem of the fistula prosthesis broke when they were placing it in a patient. The physician reported that they had to take the patient to the operating room to retrieve the esophageal side of the fistula prosthesis. The physician successfully removed the esophageal side of the device. See scanned page.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025182-2015-00001 |
| MDR Report Key | 4501970 |
| Report Source | 05 |
| Date Received | 2015-02-06 |
| Date of Report | 2015-01-28 |
| Date of Event | 2015-01-28 |
| Date Mfgr Received | 2015-01-28 |
| Device Manufacturer Date | 2014-08-01 |
| Date Added to Maude | 2015-02-11 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | BELINDA JACKSON |
| Manufacturer Street | 1110 MARK AVE. |
| Manufacturer City | CARPINTERIA CA 93013 |
| Manufacturer Country | US |
| Manufacturer Postal | 93013 |
| Manufacturer Phone | 8055765308 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLOM-SINGER ADJUSTABLE BI-FLANGED FISTULA |
| Generic Name | FISTULA PROSTHESIS |
| Product Code | EWL |
| Date Received | 2015-02-06 |
| Model Number | FM1004 |
| Catalog Number | FM1004 |
| Lot Number | 1097806 |
| Device Expiration Date | 2017-08-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HELIX MEDICAL, LLC |
| Manufacturer Address | CARPINTERIA CA 93013 US 93013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-02-06 |