MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-03-29 for DOBBHOFF FEEDING TUBE 8884710834 manufactured by Sherwood Medical Co..
[18468]
Metallic tip of feeding tube broke off, apparently perforating the colon requiring surgical intervention for removal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 32312 |
| MDR Report Key | 32312 |
| Date Received | 1996-03-29 |
| Date of Report | 1996-03-28 |
| Date of Event | 1995-07-28 |
| Date Facility Aware | 1996-03-28 |
| Report Date | 1996-03-28 |
| Date Reported to FDA | 1996-03-28 |
| Date Reported to Mfgr | 1996-03-28 |
| Date Added to Maude | 1996-04-30 |
| 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 | DOBBHOFF FEEDING TUBE |
| Generic Name | FEEDING TUBE |
| Product Code | FEF |
| Date Received | 1996-03-29 |
| Model Number | 8884710834 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NO INFO |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 33583 |
| Manufacturer | SHERWOOD MEDICAL CO. |
| Manufacturer Address | 19615 OLIVE ST ST LOUIS MO 63103 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-03-29 |