MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-02-24 for UNK KELLER FUNNEL2 manufactured by Keller Medical Inc..
[101145986]
This event is being reported as a malfunction of the keller funnel device because it may have contributed to the rupture of the breast implant shell. Although there was no injury to the patient in this case, delivery of a ruptured breast implant to the breast pocket space could require additional medical intervention in the event that the rupture is not noticed by the implanting physician. Information contained in this report regarding the associated allergan breast implant device will be submitted via psr. Further information from the reporter regarding product details has been requested. No additional information is available at this time. The device is not available for return. Device labeling: caution! Using excessive force may damage the implant. If the implant does not gently advance through the funnel into the surgical pocket, similar to the amount of force required during the sizing confirmation step, stop! Ensure the distal end is not folded, pinched, wrinkled, or overly constricted. Verify that both the incision and surgical pocket are large enough to accommodate the implant. Verify the end of the funnel is not inserted more than 1 cm, is directed toward the center of the surgical pocket, and the pathway is not obstructed by muscle tissue, or surgical instruments.
Patient Sequence No: 1, Text Type: N, H10
[101145987]
Healthcare professional reported during the insertion with an allergan inspira? Smooth silicone gel filled breast implant through a keller funnel? 2, the doctor noticed a "rupture on the corner of the implant. " the doctor set the implant aside, and the procedure was successfully completed with a backup device. The device touched the patient, but it could not be confirmed if the gel itself made patient contact. The funnel was trimmed to the correct trim for the size of the breast implant and hydrated with a triple antibiotic solution.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007802878-2018-00002 |
| MDR Report Key | 7295084 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-02-24 |
| Date of Report | 2018-02-24 |
| Date of Event | 2018-01-25 |
| Date Mfgr Received | 2018-01-30 |
| Date Added to Maude | 2018-02-24 |
| 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 | KELLER MEDICAL INC. |
| Manufacturer Street | 1239 SE INDIAN ST. SUITE 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 | UNK KELLER FUNNEL2 |
| Generic Name | KIT, SURGICAL INSTRUMENT, DISPOSABLE |
| Product Code | KDD |
| Date Received | 2018-02-24 |
| Catalog Number | UNK KELLER FUNNEL2 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KELLER MEDICAL INC. |
| Manufacturer Address | 1239 SE INDIAN ST. SUITE 112 STUART FL 34997 US 34997 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-02-24 |