MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-29 for BOWER-RING PEG KIT UNKNOWN 30-3020 manufactured by Corpak, Inc..
[5603]
This 88-yr old patient pulled out his peg tube while trying to get out of bed. Examination of the peg showed the "balloon" was broken and the foam piece from inside the balloon was missing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 18577 |
| MDR Report Key | 18577 |
| Date Received | 1994-07-29 |
| Date of Report | 1994-01-31 |
| Date of Event | 1994-01-14 |
| Date Facility Aware | 1994-01-21 |
| Report Date | 1994-01-31 |
| Date Reported to Mfgr | 1994-01-31 |
| Date Added to Maude | 1994-12-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOWER-RING PEG KIT |
| Generic Name | PEG TUBE FOR GASTROSTOMY PROCEDURES |
| Product Code | FEF |
| Date Received | 1994-07-29 |
| Returned To Mfg | 1994-01-17 |
| Model Number | UNKNOWN |
| Catalog Number | 30-3020 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 18505 |
| Manufacturer | CORPAK, INC. |
| Manufacturer Address | WHEELING IL 60090 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-07-29 |