FDA Adverse Event Injury Summary report: N

SURGIFLO KIT

MDR report key: 7642719 · Received June 27, 2018

Report

Report Number: 3008478369-2018-00003
Event Type: Injury
Date Received: June 27, 2018
Product Code: LMF
Adverse Event: Yes
Report Source: Distributor report
Reporter Location: MX
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 09/23/2020. THIS MEDWATCH IS NOT REPORTABLE BY ETHICON, INC. AS THE IMPORTER BECAUSE THIS DEVICE WAS NOT IMPORTED INTO THE USA. THEREFORE, THIS MEDWATCH REPORT IS BEING VOIDED.

Description of Event or Problem · 1

THE PATIENT UNDERWENT A COLUMN SURGERY (ELECTIVE LUMBAR SPINE SURGERY, DECOMPRESSION AND FIXATION) IN (B)(6) 2017 AND AN ABSORBABLE HEMOSTAT WAS USED. THE PATIENT PRESENTED WITH LUMBAR PAIN 48 HOURS AFTER THE PROCEDURE. A CT SCAN WAS TAKEN, THE SCAN SHOWED A COLLECTION THAT LOOKED LIKE A HEMATOMA. THE PATIENT UNDERWENT AN INTERVENTION TO REMOVE THE HEMATOMA AND DRAIN IT. UPON OPENING, DURING THE RE-OPERATION, THE DOCTOR NOTICED THAT IT WAS A COLLECTION OF SEROHEMATIC LIQUID, NOT A HEMATOMA. THIS SEROHEMATIC COLLECTION WAS FORMED BY AN INFLAMMATORY REACTION, WHICH WAS CORROBORATED BY A CYTOCHEMICAL STUDY AND THE RESULT WAS 100% INFLAMMATORY. DURING THE RE-OPERATION, THE AREA WAS DRAINED. THE BEGINNING OF LOWER BACK PAIN STARTED ON (B)(6) 2016, THE SURGICAL INTERVENTION WAS ON (B)(6) 2016. THE DOCTOR STATES THAT THE PATIENT WAS VERY FAT, ALMOST OBESE. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS GOOD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
483157	SURGIFLO KIT	ABSORBABLE HEMOSTATIC	LMF		MS0011	247500

Patients

Seq	Age	Sex	Outcome	Treatment
1	70 YR		Required Intervention