MAUDE Adverse Event Report: RESHAPE LIFESCIENCES LAP BAND SYSTEM; ADJUSTABLE GASTRIC BAND

Model Number C-20365

Device Problem Insufficient Information (3190)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/06/2021

Event Type  malfunction  

Manufacturer Narrative

No further information available.

Event Description

Device incident report dir (b)(4).On (b)(6) 2020, this patient had a laparoscopic removal of a gastric band, which was noted to be uneventful, and the surgical count was noted to be correct.On (b)(6) 2020, the patient was readmitted and underwent an incision and drainage of a subcutaneous abscess.It was again an uneventful procedure and the surgical count was also correct.On (b)(6) 2021 the patient presented to this facility with erythema and a subcutaneous abscess.Patient underwent surgery for a wound debridement and exploration at which time was found to have a foreign object insitu possibly retained from a previous surgery at [redacted].This is now thought to be one of the anchors from the lap band port.Patient outcome/consequences: patient underwent to further surgical procedures and long term antibiotics.

• Brand Name: LAP BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 1001 calle amanecer; san clemente CA 92673
• Manufacturer Contact: brian stowe ; 1001 calle amanecer; san clemente, CA 92673 ; 9494817801
• MDR Report Key: 11952542
• MDR Text Key: 264091188
• Report Number: 3013508647-2021-00022
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C-20365
• Device Catalogue Number: C-20365
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other