MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-03 for KELLER FUNNEL2 (5PK) HA-005 manufactured by Allergan (keller).
[96855080]
A review of the device history record has been initiated. If any new, changed, or corrected information is noted, a supplemental medwatch will be submitted. Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time.
Patient Sequence No: 1, Text Type: N, H10
[96855081]
Healthcare professional reported there was a "piece of scrid" noticed in the package of a keller funnel? 2. No patient contact was made and the procedure was completed with a backup device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007802878-2017-00001 |
| MDR Report Key | 7160498 |
| Date Received | 2018-01-03 |
| Date of Report | 2018-01-03 |
| Date of Event | 2017-11-30 |
| Date Mfgr Received | 2017-12-04 |
| Device Manufacturer Date | 2017-06-30 |
| Date Added to Maude | 2018-01-03 |
| 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 | MS. SUZANNE WOJCIK |
| Manufacturer Street | 301 W HOWARD LANE SUITE 100 |
| Manufacturer City | AUSTIN TX 78753 |
| Manufacturer Country | US |
| Manufacturer Postal | 78753 |
| Manufacturer Phone | 7372473605 |
| Manufacturer G1 | ALLERGAN (KELLER) |
| Manufacturer Street | 1239 SE INDIAN ST STE 112 |
| Manufacturer City | STUART FL 34997 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 34997 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | KELLER FUNNEL2 (5PK) |
| Generic Name | KIT, SURGICAL INSTRUMENT, DISPOSABLE |
| Product Code | KDD |
| Date Received | 2018-01-03 |
| Catalog Number | HA-005 |
| Lot Number | H170618 |
| Device Expiration Date | 2019-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLERGAN (KELLER) |
| Manufacturer Address | 1239 SE INDIAN ST STE 112 STUART FL 34997 US 34997 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-01-03 |