MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-18 for MIC-KEY #18 FR. 2.0 CM #0120-18-2.0 manufactured by Ballard Medical Products.
[18892]
Patient had gastrostomy button placed 5/18/94. On 9/4/94, patient admitted with gastrointestinal bleed. Upon endoscopy, found four superficial erosions on gastric wall oppostie gastrostomy site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 25737 |
| MDR Report Key | 25737 |
| Date Received | 1995-01-18 |
| Date of Report | 1994-10-21 |
| Date of Event | 1994-09-04 |
| Date Facility Aware | 1994-10-03 |
| Report Date | 1994-10-21 |
| Date Reported to Mfgr | 1994-10-21 |
| Date Added to Maude | 1995-09-19 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | MIC-KEY |
| Generic Name | GASTROSTOMY BUTTON |
| Product Code | FAT |
| Date Received | 1995-01-18 |
| Model Number | #18 FR. 2.0 CM |
| Catalog Number | #0120-18-2.0 |
| Lot Number | UNAVAILABLE |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 4 MO |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 26319 |
| Manufacturer | BALLARD MEDICAL PRODUCTS |
| Manufacturer Address | 12050 LONE PEAK PARKWAYS DRAPER UT 84020 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 1995-01-18 |