MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2016-06-14 for AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE manufactured by American Medical Systems (mn).
[47287237]
(b)(4). The device was returned for evaluation; analysis results indicate one cylinder and the reservoir performed within specifications. The other cylinder sustained a hole in the outer tube that appears to be caused by a sharp instrument; the cylinder remained functional. The pump was not functionally tested due contamination by what appears to be tissue.
Patient Sequence No: 1, Text Type: N, H10
[47287238]
It was reported that following the implantation of his ams 700 inflatable penile prosthesis, the patient experienced infection. "one month post-op ((b)(6)), patient presented with scrotal cellulitis and received 2 weeks of augmentin. Patient seen in surgeon's office for scrotal incision fluctuance. Patient returned 2 days later with open incision and drained purulent fluid, scrotal redness, firmness, scrotum and suprapubic area pain with symptomatic fever and chills. Wbc count 12,000. Patient was hospitalized and received broad-spectrum iv antibiotics for 72 hours. White count normalized and cellulitis resolved. Patient taken to surgery (b)(6) 2016 for salvage, washout with removal of prosthesis and washout and placement of an ams malleable prosthesis". Patient did well post-op and discharged to home in stable condition. No further patient complications were reported in relation with this event.
Patient Sequence No: 1, Text Type: D, B5
[53466568]
Common device name from penile prosthesis to device, impotence, mechanical/hydraulic. Product code (fda) from fae to fhw. Pma/510(k) from k821628 to n970012.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2016-00129 |
| MDR Report Key | 5722405 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2016-06-14 |
| Date of Report | 2016-05-25 |
| Date of Event | 2016-05-09 |
| Date Mfgr Received | 2016-07-27 |
| Date Added to Maude | 2016-06-14 |
| 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. SHARON ZURN |
| Manufacturer Street | 10700 BREN ROAD W |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal | 55343 |
| Manufacturer Phone | 9529306000 |
| Manufacturer G1 | AMERICAN MEDICAL SYSTEMS (MN) |
| Manufacturer Street | 10700 BREN ROAD W |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE |
| Generic Name | DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC |
| Product Code | JCW |
| Date Received | 2016-06-14 |
| Returned To Mfg | 2016-05-25 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS (MN) |
| Manufacturer Address | 10700 BREN RD W MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2016-06-14 |