MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-08 for UNK IMPLANT DELIVERY FUNNEL manufactured by Allergan (keller).
[138450169]
This event is being reported as a malfunction of the keller funnel device because it may have contributed to the delamination of the breast implant shell. Although there was no injury to the patient in this case, delivery of a delaminated breast implant to the breast pocket space could require additional medical intervention in the event that the delamination is not noticed by the implanting physician. 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. This is a known potential adverse event addressed in the product labeling.
Patient Sequence No: 1, Text Type: N, H10
[138450170]
Healthcare professional reported "the rupture occurred during the introduction, inside the funnel keller".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011299751-2019-00067 |
| MDR Report Key | 8403923 |
| Date Received | 2019-03-08 |
| Date of Report | 2019-03-07 |
| Date Mfgr Received | 2019-02-08 |
| Date Added to Maude | 2019-03-08 |
| 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 | 1239 SE INDIAN ST STE 112 |
| Manufacturer City | STUART FL 34997 |
| Manufacturer Country | US |
| Manufacturer Postal | 34997 |
| Manufacturer Phone | 7722199993 |
| 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 | UNK IMPLANT DELIVERY FUNNEL |
| Generic Name | KIT, SURGICAL INSTRUMENT, DISPOSABLE |
| Product Code | KDD |
| Date Received | 2019-03-08 |
| Catalog Number | UNK IMPLANT DELIVERY FUNNEL |
| 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 | 2019-03-08 |