MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-16 for DIGESTHEALTH ENTERAL FEED DEVICE TUBE KITS UNKNOWN manufactured by Halyard Health.
[45924007]
Udi # unknown. (b)(4). The actual complaint product was not returned for evaluation. A review of the device history record is not possible as a lot number was not provided and a root cause cannot be determined. Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred. (b)(4). Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[45924008]
A medwatch report was received on 18-apr-2016, and fda report number (b)(4) was identified. The report states, a patient was having a gastrostomy feeding tube placement under moderate conscious sedation. A gastrostomy feeding tube was placed in the lumen of the stomach, guided by us and fluoro. The patient returned approximately nine months later with acute abdominal pain; the imaging showed a foreign object near the stomach along with free air. A diagnostic laparoscopy was performed to remove the object, which appears to be an internal portion of the dilator used during the gastrostomy tube placement. The patient underwent an uneventful post-op course with the return of normal bowel and bladder function. No additional information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611594-2016-00087 |
| MDR Report Key | 5658607 |
| Date Received | 2016-05-16 |
| Date of Report | 2016-04-28 |
| Date of Event | 2018-03-21 |
| Date Mfgr Received | 2018-03-21 |
| Date Added to Maude | 2016-05-16 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LISA CLARK |
| Manufacturer Street | 5405 WINDWARD PARKWAY |
| Manufacturer City | ALPHARETTA GA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal | 30004 |
| Manufacturer Phone | 4704485444 |
| Manufacturer G1 | AVENT SA DE R.L. DE C.V. |
| Manufacturer Street | CIRCUITO INDUSTIAL NO.40 COLONIA OBRERA |
| Manufacturer City | NOGALES, MEXICO |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DIGESTHEALTH ENTERAL FEED DEVICE TUBE KITS |
| Generic Name | DIGESTHEALTH ENTERAL FEED DEVICE TUBE KITS |
| Product Code | KCG |
| Date Received | 2016-05-16 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HALYARD HEALTH |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-16 |