MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-22 for KELLER FUNNEL2 (1PK) HA-001 manufactured by Allergan (keller).
[139568757]
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. The lot number is 18k01c. Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. This is a known potential adverse event addressed in the product labeling.
Patient Sequence No: 1, Text Type: N, H10
[139568758]
Healthcare professional reported that they "found a hair inside an unopened package of a keller funnel" of a keller funnel 1 pack.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011299751-2019-00070 |
| MDR Report Key | 8444031 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-03-22 |
| Date of Report | 2019-03-22 |
| Date of Event | 2019-03-05 |
| Date Mfgr Received | 2019-03-05 |
| Date Added to Maude | 2019-03-22 |
| 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 | MRS. MICHELLE BURGESS |
| 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 | 3 |
| Brand Name | KELLER FUNNEL2 (1PK) |
| Generic Name | KIT, SURGICAL INSTRUMENT, DISPOSABLE |
| Product Code | KDD |
| Date Received | 2019-03-22 |
| Catalog Number | HA-001 |
| Lot Number | NI |
| 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 | 2019-03-22 |