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.
[121724892]
Mastitis - unk etiology resulting from breast augmentation on (b)(6) 2018; 1 day post surgery, using inplant funnel surgical sleeve, pt with signs and symptoms of rash / itching which resolved, at about 1. 5 weeks post, there was purulence from wound. Pt admitted to (b)(6) and treated with iv antibiotics then had course of oral antibiotics. (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 | MW5080078 |
| MDR Report Key | 7905771 |
| 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 |