FDA Adverse Event Other Summary report: N

QUILL SRS

MDR report key: 1235687 · Received November 14, 2008

Report

Report Number: 2522801-2008-00041
Event Type: Other
Date Received: November 14, 2008
Date of Event: September 1, 2008
Report Date: November 14, 2008
Manufacturer: SURGICAL SPECIALTIES CORP. (DBA ANGIOTEC)
Product Code: NEW
PMA / PMN Number: K051609
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DATE OF EVENT IS ESTIMATED. THE IMPLANT DATE(S) ARE ESTIMATED AS SEPTEMBER 2008. A TOTAL OF FOUR (4) PRODUCT TYPES WERE REPORTED WITH THIS COMPLAINT. INFO FOR THE OTHER THREE (3) PRODUCTS IS AS FOLLOWS: MODE / CATALOG#: RA-1050Q. LOT# M428440. EXPIRATION DATE: 06/30/2010. DEVICE MFR DATE: 06/2008. 510(K)#: K071989. MODEL / CATALOG#: RA-1029Q. LOT# M344390. EXPIRATION DATE: 03/31/2010. DEVICE MFR DATE: 03/2008. 510(K)#: K051609. MODEL / CATALOG#: RA-1046Q. LOT# M329880. EXPIRATION DATE: 02/28/2010. DEVICE MFR DATE: 02/2008. 510(K)#: K051609. ALL OTHER PRODUCT INFO RECORDED ON THIS FORM IS APPLICABLE TO ALL OF THE DEVICES. THE PROD FOR EVAL WAS RECEIVED ON 11-NOVEMBER-2008. THE EVAL IS PENDING. (B) (4). QUILL SRS PDO.

Description of Event or Problem · 1

PTS THAT UNDERWENT BREAST REDUCTION AND RECONSTRUCTION SURGERY EXPERIENCED LOCALIZED TENDERNESS, DELAYED HEALING AND DRAINAGE RELATED TO EXTRUDING SECTIONS OF QUILL SRS PDO. PTS WERE TREATED BY EXCISION OF EXPOSED AREAS OF QUILL SRS AND DRESSING CHANGES; HEALING OCCURRED BY SECONDARY INTENTION. ONE (1) PT WAS TREATED EMPIRICALLY WITH ORAL ANTIBIOTICS. A CULTURE AND SENSITIVITIES TEST WAS NOT PERFORMED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	QUILL SRS	BARBED SUTURE AND NEEDLE	NEW	SURGICAL SPECIALTIES CORP. (DBA ANGIOTEC)	RA-1036Q	M322600

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	NONE MADE AVAILABLE