MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-05 for KELLER FUNNEL2 (1PK) HA-001 manufactured by Allergan (keller).
[141051204]
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
[141051205]
Healthcare professional reported "the doctor noticed the implant had a fracture and bubbles after insertion into the pocket using a keller funnel? ". One breast implant was affected by this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011299751-2019-00077 |
| MDR Report Key | 8487216 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-05 |
| Date of Report | 2019-04-05 |
| Date of Event | 2019-03-04 |
| Date Mfgr Received | 2019-03-13 |
| Date Added to Maude | 2019-04-05 |
| 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 | 2019-04-05 |
| 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 | 2019-04-05 |