SURGICAL STAPLES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-28 for SURGICAL STAPLES manufactured by Unknown.

Event Text Entries

[176951065] I had an emergency c section 14 months after a prior emergency c section and the gynecologist used staples following a tubal ligation. I am having nerve issues, bladder issues, suffered from a lot of health complications since my c section. I had filshie clips removed in (b)(6) of 2019 but i have a labia tear on mu right groin, and nerve damage still. My bladder functions at the age of a 14 yr old and i am (b)(6). I have had tests done on my bladder and have nerve conduction tests scheduled in the next few months also a test to try to figure out where the blood flow has been cut of they believe to my brain keeping me from getting proper circulation. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5092566
• MDR Report Key: 9641498
• Date Received: 2020-01-28
• Date of Report: 2020-01-27
• Date of Event: 2016-05-26
• Date Added to Maude: 2020-01-29
• 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: PATIENT
• 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: 3

Device Sequence Number: 1

• Brand Name: SURGICAL STAPLES
• Generic Name: STAPLE, IMPLANTABLE
• Product Code: GDW
• Date Received: 2020-01-28
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UNKNOWN

Device Sequence Number: 2

• Brand Name: FILSHIE CLIPS
• Generic Name: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Product Code: KNH
• Date Received: 2020-01-28
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: FEMCARE, LTD.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit	2020-01-28