SIENTRA IMPLANTS 20645-550HP (R & L)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-11 for SIENTRA IMPLANTS 20645-550HP (R & L) manufactured by Sientra Inc..

Event Text Entries

[110871667] Sientra implants severe bilateral capsular contracture and severe pain, deformity, and loss of arm range of motion.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5077787
• MDR Report Key: 7591238
• Date Received: 2018-06-11
• Date of Report: 2018-06-09
• Date of Event: 2017-09-10
• Date Added to Maude: 2018-06-12
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: UNKNOWN
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: SIENTRA IMPLANTS
• Generic Name: SIZER MAMMARY, BREAST IMPLANT VOLUME
• Product Code: MRD
• Date Received: 2018-06-11
• Model Number: 20645-550HP (R & L)
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SIENTRA INC.

Device Sequence Number: 2

• Brand Name: SIENTRA IMPLANTS
• Generic Name: SIZER MAMMARY, BREAST IMPLANT VOLUME
• Product Code: MRD
• Date Received: 2018-06-11
• Model Number: 20645-550HP (R & L)
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: SIENTRA INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit	2018-06-11