MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-11-26 for SILICONE PIP SZ. 0 SPIP-520-0-WW manufactured by Ascension Orthopedics.
[168204676]
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[168204677]
It was reported that the patient had an infection 23 days after the implantation of a silicone pip. It was treated with oral antibiotics. Additional information has been requested. 2 of 2 reports: other mfg report number: 1651501-2019-00047.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651501-2019-00048 |
| MDR Report Key | 9379390 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-11-26 |
| Date of Report | 2019-11-01 |
| Date of Event | 2019-05-07 |
| Date Mfgr Received | 2019-11-01 |
| Date Added to Maude | 2019-11-26 |
| 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 | MRS. VIVIAN NELSON |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362319 |
| Manufacturer G1 | ASCENSION ORTHOPEDICS |
| Manufacturer Street | 8700 CAMERON ROAD #100 |
| Manufacturer City | AUSTIN TX 78754 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78754 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SILICONE PIP SZ. 0 |
| Generic Name | SILICONE PIP |
| Product Code | KYJ |
| Date Received | 2019-11-26 |
| Catalog Number | SPIP-520-0-WW |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENSION ORTHOPEDICS |
| Manufacturer Address | 8700 CAMERON ROAD #100 8700 CAMERON ROAD #100 AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-26 |