GALAFLEX 3DR
Received Jun 7, 2022 · Event occurred Oct 20, 2017
Report 1213643-2022-00380 · MDR key 14622067
Device
Generic name
Breast - Absorbable Mesh
Manufacturer
Tepha, Inc. - 3005670760Model number
100043-06Catalog number
FR3D06
Lot number
170168
Product problems
- Patient-Device Incompatibility
- Patient-Device Incompatibility
Patient
33 YR · Female
- Impaired Healing
- Impaired Healing
Narrative
Additional Manufacturer Narrative
BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE. AS REPORTED, PATIENT EXPERIENCED POST-OP COMPLICATIONS INCLUDING DELAYED WOUND HEALING. MEDICAL AFFAIRS HAS ASSESSED THE PATIENT¿S POSTOPERATIVE COURSE AS BEING SERIOUS AND LIKELY RELATED TO THE STUDY DEVICE. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE DEVICE WAS MANUFACTURED TO SPECIFICATION. NOT RETURNED - REMAINS IMPLANTED.
Description of Event or Problem
PER CLINICAL TRIAL (B)(4): ON (B)(6) 2017, PATIENT UNDERWENT BILATERAL REVISION AUGMENTATION MASTOPEXY USING A VERTICAL INCISION. 2 PIECES OF GALAFLEX 3DR WERE USED. CONCOMITANT PROCEDURE WAS CAPSULECTOMY. ON (B)(6) 2017, BILATERAL DELAYED WOUND HEALING NOTED AT THE TRIFURCATIONS, WAS REPORTED. PATIENT WAS TREATED WITH NON-ADHERENT DRESSING AND POLYSPORIN APPLICATION TO THE AREAS. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2017. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE ADVERSE EVENT AS LIKELY RELATED TO THE DEVICE AND SERIOUS.