MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-06-06 for ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION 70-0060-114 SBRD-14-ENF manufactured by Xeridiem Medical Devices.
[110329162]
Patient information was not available. Event date is estimated; report date corresponds to when additional information related to reportability was received. Model number is xeridiem part number for the device. Catalog number is part number for xeridiem's exclusive distributor for the device, cook medical. Date provided is date of evaluation; actual return date may have been earlier. Conclusion code is with respect to perstomal abscess which was the reason for reportability. Balloon burst was confirmed but relationship between this failure and the reported peristomal abscess is unclear.
Patient Sequence No: 1, Text Type: N, H10
[110329163]
The tube was in place less than four weeks - split/tear in balloon. Subsequent information was received as follows: catheter was removed and 14fr halyard gastrostomy device was inserted via existing tract. Gastric aspirate obtained with ph=2. However, as tube has been in place less than four weeks, a tubogram will be required to confirm correct position prior to use. Tube remains at 6cm skin level. Entry site red, painful, inflamed and firm to the touch - peristomal abscess. Currently on clindamycin, gentamicin and flucloxacillin following skin swab.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025851-2018-00015 |
| MDR Report Key | 7576460 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-06-06 |
| Date of Report | 2018-05-07 |
| Date of Event | 2018-04-26 |
| Date Mfgr Received | 2018-05-07 |
| Date Added to Maude | 2018-06-06 |
| 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. STEVE MURRAY |
| Manufacturer Street | 4700 S. OVERLAND DRIVE |
| Manufacturer City | TUCSON AZ 857143430 |
| Manufacturer Country | US |
| Manufacturer Postal | 857143430 |
| Manufacturer Phone | 5208827794 |
| Manufacturer G1 | XERIDIEM MEDICAL DEVICES |
| Manufacturer Street | 4700 S. OVERLAND DRIVE |
| Manufacturer City | TUCSON AZ 857143430 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 857143430 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION |
| Generic Name | HSDYTPDYP,U YINR |
| Product Code | PIF |
| Date Received | 2018-06-06 |
| Returned To Mfg | 2018-05-31 |
| Model Number | 70-0060-114 |
| Catalog Number | SBRD-14-ENF |
| Lot Number | 956201 |
| Device Expiration Date | 2019-01-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XERIDIEM MEDICAL DEVICES |
| Manufacturer Address | 4700 S. OVERLAND DRIVE TUCSON AZ 857143430 US 857143430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-06 |