MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-15 for SU-POR SURGICAL IMPLANTS 4294 manufactured by Poriferous, Llc.
[175190924]
An implant required removal due to exposure. Upon examination of the removed implant, no signs of infection were present. The surgeon ordered a culture of the explanted device. Results were negative for infection. The area of tissue breakdown and exposure were located in what the surgeon described as "areas of potential pressure necrosis". If the surgical dressing cup is displaces, it is possible for the pressure on the ear to cause tissue breakdown. Also expressed by the surgeon is the difficulty to get the patient to follow post operative instructions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010781616-2020-00047 |
| MDR Report Key | 9594282 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-15 |
| Date Mfgr Received | 2019-12-10 |
| Date Added to Maude | 2020-01-15 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. KRISTA BRADSTREET |
| Manufacturer Street | 535 PINE ROAD SUITE 206 |
| Manufacturer City | NEWNAN GA 30263 |
| Manufacturer Country | US |
| Manufacturer Postal | 30263 |
| Manufacturer Phone | 7706833855 |
| Manufacturer G1 | PORIFEROUS, LLC |
| Manufacturer Street | 535 PINE ROAD SUITE 206 |
| Manufacturer City | NEWNAN GA 30263 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30263 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SU-POR SURGICAL IMPLANTS |
| Generic Name | SU-POR SURGICAL IMPLANT EAR WEDGE THIN |
| Product Code | KKY |
| Date Received | 2020-01-15 |
| Catalog Number | 4294 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PORIFEROUS, LLC |
| Manufacturer Address | 535 PINE ROAD SUITE 206 NEWNAN GA 30263 US 30263 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-15 |