MAUDE Adverse Event Report: HANSON MEDICAL, INC. POWERFLEX PEC IMPLANT; PECTORALIS IMPLANT

Model Number	ACP 2 - 2, PAIR
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Rash (2033)
Date of Event	03/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A patient had hanson medical pectoralis implants (hmi part # acp 2 - 2, pair / lot # 18309) implanted on (b)(6) 2021 by dr.(b)(6).The complaint notes indicate that the pectoralis implants were sterilized at the surgery center, however, no record or method of sterilization could be provided.The patient complained numerous times to dr.(b)(6) that he was experiencing a rash (bilaterally) which was progressing extensively.The patient was treated with medrol dosepak and antibiotics with no improvement.The patient had subsequent office visits on (b)(6) 2021.The implants were removed (explanted) on (b)(6) 2021.Hanson medical was first notified of this issue on july 12, 2021.Hanson medical (hmi) reviewed the complaint notes and emails, traced the shipping log ((b)(6) 2021), batch manufacturing record ((b)(4)), package insert ((b)(4)), and incoming inspection of raw materials ((b)(4)).The incoming inspection record shows the raw material passed all cytotoxicity tests and elemental analysis of trace metals prior to release.The package insert specifies the three approved steam sterilization cycles for hmi body contouring implants and states "never use eto ethylene oxide sterilization to sterilize this product." the investigation does not lead to a clear conclusion about the root cause of the reported adverse event.However, hmi has determined that "the device appears to elicit an undesired response in the patient to the presence of an implanted or invasive device, without inherent device failure." the patient's rash improved after explantation.
Event or Problem Description
A patient had hanson medical pectoralis implants (hmi part # acp 2 - 2, pair / lot # 18309) implanted on (b)(6) 2021 by dr.(b)(6).The complaint notes indicate that the pectoralis implants were sterilized at the surgery center, however, no record or method of sterilization could be provided.The patient complained numerous times to dr.Shah that he was experiencing a rash (bilaterally) which was progressing extensively.The patient was treated with medrol dosepak and antibiotics with no improvement.The patient had subsequent office visits on (b)(6) 2021.The implants were removed (explanted) on (b)(6) 2021.Hanson medical was first notified of this issue on july 12, 2021.

• Brand Name: POWERFLEX PEC IMPLANT
• Common Device Name: PECTORALIS IMPLANT
• Manufacturer (Section D): HANSON MEDICAL, INC.; 3527 combine street; paso robles CA 93446
• MDR Report Key: 12307523
• Report Number: 2031444-2021-00001
• Device Sequence Number: 11716794
• Product Code: MIC
• UDI-Device Identifier: B049ACP220
• UDI-Public: +B049ACP220/$$7183094
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K973729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ACP 2 - 2, PAIR
• Device Catalogue Number: ACP 2 - 2, PAIR
• Device Lot Number: 18309
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 50 YR