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 2017-06-05 for AEROFORM? TISSUE EXPANDER SYSTEM, MEDIUM, V2.5 LP120-650 manufactured by Airxpanders, Inc..
[76709542]
The right tissue expander s/n (b)(4) is not available for evaluation as it remains implanted until the patient's planned radiation treatment has concluded, and after the surgeon feels it is medically feasible to remove. The tissue expanders have been implanted for approximately 11 months (implanted on (b)(6) 2016). The aeroform? Tissue expander is not intended for implant use beyond 6 months as per its indications for use. The over-expansion of the device may be due to prolonged use of the device beyond its recommended labeled use. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[76709543]
The surgeon reported the patient had not expanded since implantation ((b)(6) 2016). The patient had not started home expansion due to multiple medical complications and visit non-compliance. On (b)(6) 2017, the surgeon planned to expand the patient to 100cc on each side prior to the patient beginning radiation treatment. The patient's left tissue expander was initially expanded by 50cc of co2 without issue. The surgeon then proceeded to expand the right side, and after approximately 20cc to 30cc expansion, it was observed the right expander continued to expand quickly and became firm resulting in discomfort to the patient. The surgeon inserted an 18-gauge needle into the right expander to deflate it to relieve patient discomfort. The patient will proceed with radiation treatment, and the expanders will be explanted when it is medically feasible to do so.
Patient Sequence No: 1, Text Type: D, B5
[108784939]
This follow up report corrects the model number previously reported. The model number for this device is lp120-650.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009130440-2017-00002 |
| MDR Report Key | 6613629 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-06-05 |
| Date of Report | 2017-06-22 |
| Date of Event | 2017-05-08 |
| Date Mfgr Received | 2017-05-08 |
| Device Manufacturer Date | 2016-05-01 |
| Date Added to Maude | 2017-06-05 |
| 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. NELLIE BUSHMAN |
| Manufacturer Street | 1047 ELWELL COURT |
| Manufacturer City | PALO ALTO CA 94303 |
| Manufacturer Country | US |
| Manufacturer Postal | 94303 |
| Manufacturer Phone | 6509641437 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AEROFORM? TISSUE EXPANDER SYSTEM, MEDIUM, V2.5 |
| Generic Name | CARBON DIOXIDE GAS CONTROLLED TISSUE EXPANDER |
| Product Code | LCJ |
| Date Received | 2017-06-05 |
| Model Number | LP120-650 |
| Catalog Number | LP120-650 |
| Lot Number | F03015 |
| Device Expiration Date | 2017-04-30 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | AIRXPANDERS, INC. |
| Manufacturer Address | 1047 ELWELL COURT PALO ALTO CA 94303 US 94303 |
| Brand Name | AEROFORM? TISSUE EXPANDER SYSTEM, MEDIUM, V2.5 |
| Generic Name | CARBON DIOXIDE GAS CONTROLLED TISSUE EXPANDER |
| Product Code | PQN |
| Date Received | 2017-06-05 |
| Returned To Mfg | 2017-12-15 |
| Model Number | LP120-650 |
| Catalog Number | LP120-650 |
| Lot Number | F03015 |
| Device Expiration Date | 2017-04-30 |
| Operator | PHYSICIAN |
| 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 | 1047 ELWELL COURT PALO ALTO CA 94303 US 94303 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-06-05 |