MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-24 for INPLANT FUNNEL IN-001 manufactured by Proximate Concepts, Llc.
[121725374]
Mastitis unk etiology resulting from (b)(6) 2018 breast surgery - inplant funnel surgical sleeve used for surgery; approx 1 week post procedure, implants were removed. All lab tests / cultures tested negative. (two other separate incidents possibly related to use of this medical device; 2 other separate reports submitted to fda, describing the incidents. )
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080079 |
| MDR Report Key | 7905772 |
| Date Received | 2018-09-24 |
| Date of Report | 2018-09-10 |
| Date of Event | 2018-06-01 |
| Date Added to Maude | 2018-09-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INPLANT FUNNEL |
| Generic Name | KIT SURGICAL INSTRUMENT, DISPOSABLE |
| Product Code | KDD |
| Date Received | 2018-09-24 |
| Model Number | IN-001 |
| Lot Number | 042018 |
| Device Expiration Date | 2019-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROXIMATE CONCEPTS, LLC |
| Manufacturer Address | FORT LEE NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-09-24 |