GELFOAM STERILE SPONGE

MDR report key: 71661 · Received February 21, 1997

Report

Report Number: 1810189-1997-00004
Event Type: Malfunction
Date Received: February 21, 1997
Date of Event: November 19, 1996
Report Date: January 20, 1997
Manufacturer: PHARMACIA & UPJOHN CO.
Product Code: LMF
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

SEE BOX B-6 FOR DISCUSSION REGARDING QUALITY CONTROL RESULTS OF RETAINED SAMPLE.

Description of Event or Problem · 1

THIS REPORT WAS RECEIVED FROM AN ENT PHYSICIAN ASKING IF THERE HAD BEEN A FORMULATION CHANGE OF THE SPONGE. HE HAD BEEN USING THE PRODUCT FOR THE PAST FIFTEEN YRS FOR TYMPANIC MEMBRANE GRAFTING WITH NO PROBLEMS. HE APPLIES THE SPONGE DURING THE PROCEDURE AND THEN REMOVES IT 1-2 WEEKS LATER. HE HAD ALWAYS BEEN ABLE TO VACUUM OUT THE SPONGE EASILY, HOWEVER, IN THE PAST FEW MONTHS, HE HAD NOTICED AT THE TIME OF REMOVAL (OF THE SPONGE) IT HAD BECOME DENSE AND ADHERED TO THE MIDDLE EAR TISSUE WHICH REQUIRED SCRAPING TO REMOVE. THIS RESULTED IN DISCOMFORT TO THE PT AND PROLONGED USE OF ANTIBIOTIC EAR DROPS. HE REPORTED FOUR PTS OF HIS AND TWO PTS IN WHICH HIS PARTNER HAD THE SAME PROBLEM. ACCORDING TO CO'S QUALITY ASSURANCE AREA, THERE HAD BEEN NO FORMULATION CHANGE IN THE PRODUCT. A DOWNWARD TREND IN THE DIGESTIBILITY OF THE PRODUCT HAD BEEN SEEN, HOWEVER, THIS IS WELL WITHIN PRODUCT SPECIFICATIONS. ADD'L INFO IS BEING SOUGHT FOR EACH PT SEPARATELY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	GELFOAM STERILE SPONGE Implant	ABSORBABLE GELATIN SPONGE	LMF	PHARMACIA & UPJOHN CO.	SIZE 12X7	61AHF

Patients

Seq	Age	Sex	Outcome	Treatment
1	9 YR		Required Intervention