MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2011-03-11 for ULTRATHANE WILLS-OGLESBY SINGLE LUMEN PERCUTANEOUS GASTROSTOMY SET WOGS-1200 manufactured by Cook, Inc..
[1955968]
Post insertion, the tube leaked gastric content causing superficial acid burn to the left side of the pt's abdomen. Add'l info was requested but not provided.
Patient Sequence No: 1, Text Type: D, B5
[9221339]
Exp date unk as lot is unk. (b)(4): superficial acid burn. No product was returned. An ifu is provided with this device that describes proper insertion and usage. Per the quality control spec it is confirmed the flare is not folded over in adapter, the adapter is secure, and that the sleeve is positioned correctly. No device was returned to assist in our investigation. Add'l info as to the location of the leakage was requested, but not provided. Without add'l info we are unable to determine where the leakage originated from or what may have led to the leakage. We will continue to monitor for similar complaints, have notified the appropriate personnel. Quality engineering risk assessment determined that no further mitigating action is necessary at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2011-00120 |
| MDR Report Key | 2022193 |
| Report Source | 01,08 |
| Date Received | 2011-03-11 |
| Date of Report | 2011-02-09 |
| Date of Event | 2011-01-31 |
| Date Facility Aware | 2011-01-31 |
| Report Date | 2011-02-09 |
| Date Mfgr Received | 2011-02-10 |
| Date Added to Maude | 2011-03-24 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | RITA HARDEN, MANAGER |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRATHANE WILLS-OGLESBY SINGLE LUMEN PERCUTANEOUS GASTROSTOMY SET |
| Generic Name | EZK CATHETER, RETENTION TYPE |
| Product Code | EZK |
| Date Received | 2011-03-11 |
| Model Number | NA |
| Catalog Number | WOGS-1200 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-11 |