DISPOSABLE FURLOW TOOL
Received Jul 9, 2024 · Event occurred May 20, 2024
Report 2124215-2024-41924 · MDR key 19701415
Device
Generic name
Penile Implant Surgical Accessories
Manufacturer
Boston Scientific CorporationModel number
UNK-P-DISPOSABLE_FURLOW_TOOLCatalog number
UNK-P-DISPOSABLE_FURLOW_TOOL
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
70 YR · Male
- Hematoma
- Hematoma
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION PROVIDED TO UPDATE B5 DESCRIBE EVENT/PROBLEM. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UDI AND OTHER SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT ENROLLED IN THE IT MATTERS STUDY AND WAS IMPLANTED WITH THIS AMBICOR PENILE PROSTHESIS (APP) ON (B)(6) 2024. TWENTY-SIX DAYS POST IMPLANT, THE PATIENT PRESENTED WITH HEMATOMA IN FRONT OF THE PUMP. THE PHYSICIAN SUSPECTED THAT THE HEMATOMA WAS A RESULT OF THE FURLOW INSERTION TOOL. THERE HAS BEEN NO SURGICAL INTERVENTION AND NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED. THE HEMATOMA WAS RESOLVED ON (B)(6) 2024.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT ENROLLED IN THE IT MATTERS STUDY AND WAS IMPLANTED WITH THIS AMBICOR PENILE PROSTHESIS (APP) ON (B)(6) 2024. TWENTY SIX DAYS POST IMPLANT, THE PATIENT PRESENTED WITH HEMATOMA IN FRONT OF THE PUMP. THE PHYSICIAN SUSPECTED THAT THE HEMATOMA WAS A RESULT OF THE FURLOW INSERTION TOOL. THERE HAS BEEN NO SURGICAL INTERVENTION AND NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.
Additional Manufacturer Narrative
CORRECTION TO D1 BRAND NAME, D2A COMMON DEVICE NAME, D2B PRO CODE (PRODUCT CODE), D4 MODEL NUMBER, D4 CATALOG NUMBER, D4 UNIQUE IDENTIFIER, D6A IMPLANT DATE, D5 OPERATOR OF DEVICE, H6 IMPACT CODES.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT ENROLLED IN THE IT MATTERS STUDY AND WAS IMPLANTED WITH THIS AMBICOR PENILE PROSTHESIS (APP) ON (B)(6) 2024. TWENTY SIX DAYS POST IMPLANT, THE PATIENT PRESENTED WITH HEMATOMA IN FRONT OF THE PUMP. THE PHYSICIAN SUSPECTED THAT THE HEMATOMA WAS A RESULT OF THE FURLOW INSERTION TOOL. THERE HAS BEEN NO SURGICAL INTERVENTION AND NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.