AMS 700 LGX MS PUMP IZ/PRECONNECTED - PENOSCROTAL 72404252

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-29 for AMS 700 LGX MS PUMP IZ/PRECONNECTED - PENOSCROTAL 72404252 manufactured by American Medical Systems, Inc..

Event Text Entries

[125298124] Patient calls risk manager to complain that he has an infection that required his penile implant to be removed a week prior. He said he had a penile implant surgery a month prior. He said doctor told him the organism was very unusual per his surgeon and was surprised he had not been contacted by the hospital already. I told him i did not know about his situation, but infection control may and he asked if he should contact them and i told him i could do that. He said he wanted something done and wanted to know whom he should contact. He had his wife on the extension as well. I told him i would place his bill on hold while i conducted an investigation, and would get back to him early next week. American medical systems, model # 72404252. Spoke with surgeon and explained how patient had inferred that this was such an unusual infection. Doctor said it was pseudomonas, which is not the most common, but not rare or uncommon. He had not indicated to the patient that we or the hospital had caused the infection, but rather these do occur. He identified the patient is a diabetic which makes him a higher risk for infection. Doctor could not speculate where the infection came from; it could have come from anywhere. Patient is doing well and he had seen the patient in his office this day and was surprised the patient had called risk management. Spoke with infection preventionist registered nurse. She said that she had seen this case and it was a surgical site infection (ssi), and that pseudomonas was not an unusual infection. She had reviewed the case and found all prevention efforts had been taken. The correct antibiotics were given. The glucose was maintained in good control. She reported that penile implants are not followed or reportable to the cdc, but we do follow them in-house and all preventive measures had been taken. When this patient came in for the implant he completed his antisepsis protocol in pre-op at 6:19, he received his ancef 2 grams at 7:22 and his cut time was 8:06. In surgery gentamicin 160mg in normal saline was used for irrigation and neomycin/polymyxin/bacitracin was used as a topical. Not sure how the patient could have been covered any better with antibiotics. Implant is not available for return.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8013566
MDR Report Key8013566
Date Received2018-10-29
Date of Report2018-10-24
Date of Event2018-06-25
Report Date2018-10-24
Date Reported to FDA2018-10-24
Date Reported to Mfgr2018-10-29
Date Added to Maude2018-10-29
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAMS 700 LGX MS PUMP IZ/PRECONNECTED - PENOSCROTAL
Generic NamePROSTHESIS, PENIS, INFLATABLE
Product CodeJCW
Date Received2018-10-29
Model Number72404252
Lot Number1000074023
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerAMERICAN MEDICAL SYSTEMS, INC.
Manufacturer Address10700 BREN ROAD WEST MINNETONKA MN 55343 US 55343


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-10-29

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