FDA Adverse Event Injury Summary report: N

ZYPLAST COLLAGEN IMPLANT

MDR report key: 58979 · Received December 27, 1996

Report

Report Number: 2939859-1996-00098
Event Type: Injury
Date Received: December 27, 1996
Date of Event: November 20, 1996
Report Date: December 20, 1996
Manufacturer: COLLAGEN CORP.
Product Code: LMH
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: WI, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ON JULY 7, 1997, FOLLOW UP INFO WAS RECEIVED. THE PT WAITED TO REPORT THE SYMPTOMS UNTIL DECEMBER 10, 1996. THERE HAS BEEN THICKENING IN THE TREATED AREAS, AND ONE TREATED AREA WAS RED, BUT THE SYMPTOMS HAD RESOLVED WHEN SHE CALLED ON DECEMBER 10, 1996. THE SYMPTOMS REMAINED RESOLVED WHEN SHE WAS SEEN FOR UNRELATED MATTERS ON MAY 15, 1997, MAY 29, 1997, AND JUNE 6, 1997.

Description of Event or Problem · 1

A PT REPORTED RECEIVING A TREATMENT ON 10/28/96 IN THE ORAL COMMISSURES, GLABELLA, AND ONE VERTICAL LINE ABOVE THE UPPER LIP. ON 11/20/96, THE PT DEVELOPED SWELLING AND REDNESS AT THE RIRGHT ORAL COMMISSURE TREATMENT SITE. ON APPROX 11/26/96, THE PT NOTES SWELLING AT THE LEFT ORAL COMMISURE TREATMENT SITE. ON 12/1/96, SHE ALLEGED DEVELOPMENT AT THE GLABELLAR TREATMENT SITE OF PAIN, ITCHING, AND SWELLING WHICH EXTENDED TOWARD THE RIGHT SIDE OF THE BRIDGE OF THE NOSE. ON 12/6/96, THE REDNESS AT THE RIGHT ORAL COMMISSURE TREATMENT SITE RESOLVED. ON 12/11/96, THE PT REPORTED CONTINUING SYMPTOMS TO THE PHYSICIAN WHO DIAGNOSED A HYPERSENSITIVITY; ORAL BENADRYL WAS PRESCRIBED. ON 12/15/96, A CONSULTING PHYSICIAN PRESCRIBED ORAL MEDROL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ZYPLAST COLLAGEN IMPLANT Implant	GAX	LMH	COLLAGEN CORP.	NA	96A017C

Patients

Seq	Age	Sex	Outcome	Treatment
1	45 YR		Required Intervention	(FROM 94).\| PREMARIN (FROM 93), PROZAC (FROM 91), CORGARD