MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-09-03 for AMS 700 INFLATABLE PENILE PROSTHESIS 72404324 manufactured by American Medical Systems, Inc..
[20952022]
A (b)(6) male was implanted with an ipp device on (b)(6) 2009. Pt measured left and right proximal 12 cm and distal 10cm. The 4. 0cm rtes were used with an 18cm device, measuring 22cm. On (b)(6) 2009, the 4. 0cm rtes were removed and 3. 0cm rtes were implanted. Pt's proximal and distal measurements were re-done measuring both right and left proximal at 11 and distal at 10cm, total measurement equaled 21cm not 22cm. Ams has requested additional info.
Patient Sequence No: 1, Text Type: D, B5
[21202935]
It appears the event was not related to a device malfunction but related to the size of the device and corporal measurements. No components were returned for eval. Is sufficiently captured in our risk analysis. Is sufficiently included in the product labeling. Three attempts have been made to obtain additional info and were unsuccessful. Should additional info become available regarding a revision surgery, it will be re-evaluated and a follow-up report sent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2010-00336 |
| MDR Report Key | 1842686 |
| Report Source | 05 |
| Date Received | 2010-09-03 |
| Date of Report | 2009-11-20 |
| Date of Event | 2009-11-20 |
| Date Mfgr Received | 2009-11-20 |
| Device Manufacturer Date | 2009-05-01 |
| Date Added to Maude | 2010-09-27 |
| 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 | CAROL SCHMOCK, MDR CONTACT |
| Manufacturer Street | 10700 BREN RD., WEST |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal | 55343 |
| Manufacturer Phone | 9529306425 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMS 700 INFLATABLE PENILE PROSTHESIS |
| Generic Name | IPP |
| Product Code | JCW |
| Date Received | 2010-09-03 |
| Model Number | 72404324 |
| Catalog Number | 72404324 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 10700 BREN RD., WEST MINNETONKA MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2010-09-03 |