MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2009-06-26 for ULTRATHANE WILLS-OGLESBY SINGLE LUMEN PERCUTANEOUS GASTROSTOMY SET WOGS-1200 manufactured by Cook, Inc..
[1100304]
Cook gastrostomy feeding tube was placed in 2009, pulled away from the plastic hub and the thread broke in the same month. It could not be reattached, and the tube had to be replaced. We were later advised that this was an accidental event as they cut the thread because they did not know what it was. The pt was taken to rehab and then released.
Patient Sequence No: 1, Text Type: D, B5
[8434220]
Expiration date unk as lot is unk. Evaluation: still under investigation at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2009-00356 |
| MDR Report Key | 1413342 |
| Report Source | 00 |
| Date Received | 2009-06-26 |
| Date of Report | 2009-05-29 |
| Date of Event | 2009-01-26 |
| Date Facility Aware | 2009-01-26 |
| Report Date | 2009-05-29 |
| Date Mfgr Received | 2009-05-29 |
| Date Added to Maude | 2009-07-17 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | RITA HARDEN, MGR |
| 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 | 2009-06-26 |
| Model Number | NA |
| Catalog Number | WOGS-1200 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2009-06-26 |