MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-06-24 for CONTROLLER VEST 104 P105CM manufactured by Hillrom Services Private Limited.
[16988213]
The consumer reported that the vest had broken her breast implants. She was not sure that it did because they did not go flat immediately. The consumer stated she used the vest for a very short period of time, approximately six weeks before she noticed the breast implant issue. The consumer stated she had surgery to repair her breast implants on (b)(6) of 2013. The patient's pulmonologist suggested that she contacted hill-rom to see if a vest was available that would fit under her breast. The patient feels the vest did not help her lung issue and that it did not loosen the mucus that her condition produces. The vest was used in the patient's home. This report was filed in our complaint handling system as complaint #(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[17076293]
A hill-rom representative spoke with the patient to ask about additional information regarding her breast implant leaking. The patient could not confirm that the vest caused the leak in her breast implant. It was a slow leak that let to her having surgery to repair in (b)(6) 2013. No other surgery or medical treatment was sought. The patient stated using the vest for a preexisting condition of bronchiectasis. She stopped using the vest in (b)(6) of 2013. The patient did not allege any malfunction with the vest. The risk of saline breast implant deflation is about 1% per implant per year. Silicone gel breast implant rupture rate is about (b)(4) during the first four years, which make the roughly equivalent during that time frame. Breast implants are engineered to withstand a large amount of sudden pressure and an even larger amount of gradually increasing pressure. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008145987-2014-00007 |
| MDR Report Key | 3982587 |
| Report Source | 04 |
| Date Received | 2014-06-24 |
| Date of Report | 2014-01-13 |
| Date of Event | 2013-06-10 |
| Date Mfgr Received | 2014-01-13 |
| Date Added to Maude | 2014-08-13 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JENNIFER MORRIS |
| Manufacturer Street | 1069 STATE ROUTE 46 EAST |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 8129313121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTROLLER VEST 104 |
| Generic Name | VEST |
| Product Code | BYI |
| Date Received | 2014-06-24 |
| Model Number | P105CM |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILLROM SERVICES PRIVATE LIMITED |
| Manufacturer Address | SINGAPORE, NORTH EAST 768923 SN 768923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2014-06-24 |