MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-03-26 for AEROFORM? TISSUE EXPANDER SYSTEM, MEDIUM, V3.0 FGS-0012-02 BR140-600 manufactured by Airxpanders, Inc..
[103490766]
Device investigation has not yet concluded. Preliminary investigation shows that this report was not an uncontrolled expansion, but instead a slow closing valve. A follow-up report will be provided upon conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[103490767]
On 24-feb-2018 it was reported that on (b)(6) 2018 the left expander "filled uncontrollably causing substantial pain and change in breast size" during expansion at home. The patient was administering one dose (10 cc) every three days according to the surgeon's report. The patient pressed the dosage controller for a single dose and felt the expander continue expanding. The surgeon reports the patient was directed to the er where the er doctor "used a needle to puncture and deflate the device". The surgeon states that treatment was proceeding normally for this patient prior to this event. The patient had attended 6 or 7 post-operation visits and no concerns were brought up at these times. Chemotherapy had been a part of the patient treatment plan, but had concluded prior to the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3014023351-2018-00001 |
| MDR Report Key | 7371546 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-03-26 |
| Date of Report | 2018-02-24 |
| Date of Event | 2018-08-02 |
| Date Mfgr Received | 2018-02-24 |
| Device Manufacturer Date | 2017-04-30 |
| Date Added to Maude | 2018-03-26 |
| 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 | MR. JIM CHURCHHILL |
| Manufacturer Street | 3047 ORCHARD PARKWAY |
| Manufacturer City | SAN JOSE CA 951342024 |
| Manufacturer Country | US |
| Manufacturer Postal | 951342024 |
| Manufacturer Phone | 8773492479 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AEROFORM? TISSUE EXPANDER SYSTEM, MEDIUM, V3.0 |
| Generic Name | CARBON DIOXIDE GAS CONTROLLED TISSUE EXPANDER |
| Product Code | PQN |
| Date Received | 2018-03-26 |
| Returned To Mfg | 2018-03-02 |
| Model Number | FGS-0012-02 |
| Catalog Number | BR140-600 |
| Lot Number | F03062 |
| Device Expiration Date | 2018-03-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AIRXPANDERS, INC. |
| Manufacturer Address | 3047 ORCHARD PKWY SAN JOSE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-03-26 |