MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-12 for FOOTPRINT MEDICAL FEEDING TUBE 4.0 FR. POLYURETHANE, ENTERAL ONLY P1FTS4.0-EO manufactured by Footprint Medical Inc..
[25399802]
No patient injury. No product failure. No product defects. Analysis reports sent to initial reporter and follow-up contact by sales department requested.
Patient Sequence No: 1, Text Type: N, H10
[25399803]
Two separate naso-gastric feeding tubes were reported to be leaking during aspiration (vacuum applied to tube) shortly after insertion in the patient. No patient injury occurred. The tubes were simply removed and replaced with a new tube.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007697249-2014-12001 |
| MDR Report Key | 5046530 |
| Date Received | 2015-08-12 |
| Date of Report | 2015-01-14 |
| Date of Event | 2014-11-04 |
| Date Mfgr Received | 2014-12-17 |
| Device Manufacturer Date | 2014-10-01 |
| Date Added to Maude | 2015-09-01 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ROBERT DAVIS |
| Manufacturer Street | 12727 CIMARRON PATH |
| Manufacturer City | SAN ANTONIO TX 782493405 |
| Manufacturer Country | US |
| Manufacturer Postal | 782493405 |
| Manufacturer Phone | 2102262600 |
| Manufacturer G1 | FOOTPRINT MEDICAL INC. |
| Manufacturer Street | 12727 CIMARRON PATH |
| Manufacturer City | SAN ANTONIO TX 782493405 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 782493405 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FOOTPRINT MEDICAL FEEDING TUBE 4.0 FR. POLYURETHANE, ENTERAL ONLY |
| Generic Name | NASO-GASTRIC FEEDING TUBE |
| Product Code | BSS |
| Date Received | 2015-08-12 |
| Returned To Mfg | 2015-01-05 |
| Model Number | P1FTS4.0-EO |
| Lot Number | 14371 |
| Device Expiration Date | 2017-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FOOTPRINT MEDICAL INC. |
| Manufacturer Address | 12727 CIMARRON PATH SAN ANTONIO TX 782493405 US 782493405 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-12 |