MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-06 for VEST MODEL 105 P105 manufactured by Hill-rom Singapore.
[119486617]
The patient had silicone shell/saline filled breast implants placed in 2008. Breast implants are not lifetime devices and the longer they remain, the more likely the patient is to experience complications. It is commonly recommended that implants be replaced prophylactically between 10 to 15 years post placement. Even when leaking is not suspected, some leakage is found to be present when the implants are replaced. It is a known possibility for implants to move or change position over time due to a large implant pocket and the positioning of the implant related to the pectoral muscle. The implants are placed under the pectoralis muscle and therefore prone to movement and mobility. Additionally, movement or flipping of the implant can occur with vigorous massage of the breasts. Initially, the patient alleged the left breast implant deflated (leaked) based on the pulmonologist? S review of the chest ct. However, the plastic surgeon believes the implant has flipped/changed positions possibly due to use of the vest. Regardless, if leaking or flipped, the implants will be removed. Neither physician has recommended to discontinue the vest therapy. The other implant is unaffected. The development of a breast implant leak, or repositioning cannot be only attributed to performance of the vest. Leaks and repositioning commonly occur due to age of the implant, patient physiology and size of the implant pocket. The vest functioned as designed, and a malfunction was not alleged. The repositioned breast implant will require surgical intervention and therefore meets the definition of a reportable event.
Patient Sequence No: 1, Text Type: N, H10
[119486618]
Hill-rom received a report from the patient stating one of her breast implants has flipped and leaked. The unit is located at the patients home. This report was filed in our complaint handling system as complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008145987-2018-00003 |
| MDR Report Key | 7852381 |
| Date Received | 2018-09-06 |
| Date of Report | 2018-08-08 |
| Date of Event | 2018-08-03 |
| Date Mfgr Received | 2018-08-08 |
| Date Added to Maude | 2018-09-06 |
| 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 | TONY WERNER |
| Manufacturer Street | 1069 STATE ROUTE 46 EAST |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 8129312359 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VEST MODEL 105 |
| Generic Name | PERCUSSOR, POWERED-ELECTRIC |
| Product Code | BYI |
| Date Received | 2018-09-06 |
| Model Number | P105 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM SINGAPORE |
| Manufacturer Address | 1 YISHUN AVENUE 7 SINGAPORE, NORTH EAST 768923 SN 768923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-06 |