| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | BARD DISPOZ-A-BAG LEG BAG WITH FLIP-FLO DRAINAGE VALVE, FABRIC LEG STRAPS, 18IN | LEG BAG | PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 | FAQ | 150832 | UNK | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-04-11 | 0 | 1. O |
Patient 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.
Patient 1
IT WAS REPORTED THAT THE PATIENT ALLEGEDLY DEVELOPED A SKIN ULCER AFTER BEING IN CONTACT WITH THE EXTENSION TUBING OF THE LEG BAG. THE PATIENT IS CURRENTLY BED RIDDEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED. CLINICAL ASSESSMENT OF PHOTOS: PHOTO TITLED "(B)(6) INJURY FROM TUBING"-PATIENT IS LAYING ON THEIR BACK. IRREGULAR SHAPED PINK AREA WITH YELLOW BLISTER. WOUND IS SUPERFICIAL WITH SKIN INTACT. DEFINED EDGES. BLISTER APPEARS FLUID FILLED. PHOTO TITLED "(B)(6) LATEX RUBBER TUBING THAT I USE"- PATIENT IS LAYING ON THEIR BACK. SHOWS WOUND ON RIGHT HIP, IRREGULAR SHAPED, PINK AREA WITH BLISTER. WOUND IS SUPERFICIAL WITH SKIN INTACT. DEFINED EDGES. BLISTER APPEARS FLUID FILLED. PHOTO TITLED "(B)(6) INJURY FROM TUBING"- PATIENT IS LAYING ON THEIR BACK. WOUND ON RIGHT HIP, IRREGULAR SHAPED, PINK AREA WITH BLISTER. WOUND IS SUPERFICIAL WITH SKIN INTACT. DEFINED EDGES. BLISTER APPEARS FLUID FILLED. PHOTO TITLED "(B)(6) INJURY FROM TUBING RIGHT HIP"- PATIENT IS LAYING ON LEFT SIDE. WOUND ON RIGHT HIP, IRREGULAR SHAPED, PINK AREA WITH BLISTER APPEARS BIGGER THAN PREVIOUS PHOTOS. WOUND IS SUPERFICIAL WITH SKIN INTACT. DEFINED EDGES. BLISTER APPEARS FLUID FILLED. PHOTO TITLED "(B)(6) WOUND BAD TISSUE" - WOUND IS PINK WITH 80% WHITE BED. ONE AREA OF BED TISSUE IN CENTER IS GRAY AND RAISED. PARTIAL THICKNESS, IRREGULAR SHAPED. THERE DOES NOT APPEAR TO BE ANY FLUID DRAINAGE, WELL DEFINED EDGES. PHOTO TITLED "(B)(6) BAD TISSUE"- WOUND IS PINK ON EDGES WITH CREAM BED. WOUND APPEARS TO BE HEALING DUE TO THE BED AS BEEN SEPARATED INTO 2 AREAS BY PINK SKIN FORMING A BRIDGE ACROSS THE WOUND. EDGES ARE LESS DEFINED. BRIGHT PINK SKIN AROUND EDGES INDICATING NEW TISSUE GROW. THERE APPEARS TO NOT BE ANY DRAINAGE.
Patient 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. THE DEVICE WAS NOT RETURNED.
Patient 1
IT WAS REPORTED THAT THE PATIENT ALLEGEDLY DEVELOPED A SKIN ULCER AFTER BEING IN CONTACT WITH THE EXTENSION TUBING OF THE LEG BAG. THE PATIENT IS CURRENTLY BED RIDDEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED. CLINICAL ASSESSMENT OF PHOTOS: PHOTO TITLED "(B)(6) INJURY FROM TUBING"-PATIENT IS LAYING ON THEIR BACK. IRREGULAR SHAPED PINK AREA WITH YELLOW BLISTER. WOUND IS SUPERFICIAL WITH SKIN INTACT. DEFINED EDGES. BLISTER APPEARS FLUID FILLED. PHOTO TITLED "(B)(6) LATEX RUBBER TUBING THAT I USE"- PATIENT IS LAYING ON THEIR BACK. SHOWS WOUND ON RIGHT HIP, IRREGULAR SHAPED, PINK AREA WITH BLISTER. WOUND IS SUPERFICIAL WITH SKIN INTACT. DEFINED EDGES. BLISTER APPEARS FLUID FILLED. PHOTO TITLED "(B)(6) INJURY FROM TUBING"- PATIENT IS LAYING ON THEIR BACK. WOUND ON RIGHT HIP, IRREGULAR SHAPED, PINK AREA WITH BLISTER. WOUND IS SUPERFICIAL WITH SKIN INTACT. DEFINED EDGES. BLISTER APPEARS FLUID FILLED. PHOTO TITLED "(B)(6) INJURY FROM TUBING RIGHT HIP"- PATIENT IS LAYING ON LEFT SIDE. WOUND ON RIGHT HIP, IRREGULAR SHAPED, PINK AREA WITH BLISTER APPEARS BIGGER THAN PREVIOUS PHOTOS. WOUND IS SUPERFICIAL WITH SKIN INTACT. DEFINED EDGES. BLISTER APPEARS FLUID FILLED. PHOTO TITLED "(B)(6) WOUND BAD TISSUE" - WOUND IS PINK WITH 80% WHITE BED. ONE AREA OF BED TISSUE IN CENTER IS GRAY AND RAISED. PARTIAL THICKNESS, IRREGULAR SHAPED. THERE DOES NOT APPEAR TO BE ANY FLUID DRAINAGE, WELL DEFINED EDGES. PHOTO TITLED "(B)(6) BAD TISSUE"- WOUND IS PINK ON EDGES WITH CREAM BED. WOUND APPEARS TO BE HEALING DUE TO THE BED AS BEEN SEPARATED INTO 2 AREAS BY PINK SKIN FORMING A BRIDGE ACROSS THE WOUND. EDGES ARE LESS DEFINED. BRIGHT PINK SKIN AROUND EDGES INDICATING NEW TISSUE GROW. THERE APPEARS TO NOT BE ANY DRAINAGE.
Patient 1
NO SAMPLE WAS RETURNED FOR EVALUATION; HOWEVER, A PHOTO SAMPLE WAS RECEIVED. THE PHOTO SAMPLE WAS EVALUATED AND THE REPORTED ISSUE COULD BE CONFIRMED; HOWEVER, THE CAUSE IS UNKNOWN , AS THE PRODUCT SHOWN IN THE PICTURES IS NOT A BARD PRODUCT. PER SPECIFICATION (EI-PS 150832 REV.13) OUR PRODUCT DOES NOT CONTAIN LATEX. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "- STERILE UNLESS PACKAGE IS OPEN OR DAMAGE. BARD? DISPOZ-A-BAG? ACCESSORIES: ? LEG BAG HOLDER ? 1-3/4? WIDE LEG BAG STRAP ? DELUXE FABRIC LEG BAG STRAPS ? EXTENSION TUBING CONTACT C. R. BARD, INC. FOR INFORMATION ON THESE AND OTHER ACCESSORIES." (B)(4). THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. THE DEVICE WAS NOT RETURNED.
Patient 1
IT WAS REPORTED THAT THE PATIENT ALLEGEDLY DEVELOPED A SKIN ULCER AFTER BEING IN CONTACT WITH THE EXTENSION TUBING OF THE LEG BAG. THE PATIENT IS CURRENTLY BED RIDDEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED. CLINICAL ASSESSMENT OF PHOTOS: PHOTO TITLED "(B)(6) INJURY FROM TUBING"-PATIENT IS LAYING ON THEIR BACK. IRREGULAR SHAPED PINK AREA WITH YELLOW BLISTER. WOUND IS SUPERFICIAL WITH SKIN INTACT. DEFINED EDGES. BLISTER APPEARS FLUID FILLED. PHOTO TITLED "(B)(6) LATEX RUBBER TUBING THAT I USE"- PATIENT IS LAYING ON THEIR BACK. SHOWS WOUND ON RIGHT HIP, IRREGULAR SHAPED, PINK AREA WITH BLISTER. WOUND IS SUPERFICIAL WITH SKIN INTACT. DEFINED EDGES. BLISTER APPEARS FLUID FILLED. PHOTO TITLED "(B)(6) INJURY FROM TUBING"- PATIENT IS LAYING ON THEIR BACK. WOUND ON RIGHT HIP, IRREGULAR SHAPED, PINK AREA WITH BLISTER. WOUND IS SUPERFICIAL WITH SKIN INTACT. DEFINED EDGES. BLISTER APPEARS FLUID FILLED. PHOTO TITLED "(B)(6) INJURY FROM TUBING RIGHT HIP"- PATIENT IS LAYING ON LEFT SIDE. WOUND ON RIGHT HIP, IRREGULAR SHAPED, PINK AREA WITH BLISTER APPEARS BIGGER THAN PREVIOUS PHOTOS. WOUND IS SUPERFICIAL WITH SKIN INTACT. DEFINED EDGES. BLISTER APPEARS FLUID FILLED. PHOTO TITLED "(B)(6) WOUND BAD TISSUE" - WOUND IS PINK WITH 80% WHITE BED. ONE AREA OF BED TISSUE IN CENTER IS GRAY AND RAISED. PARTIAL THICKNESS, IRREGULAR SHAPED. THERE DOES NOT APPEAR TO BE ANY FLUID DRAINAGE, WELL DEFINED EDGES. PHOTO TITLED "(B)(6) BAD TISSUE"- WOUND IS PINK ON EDGES WITH CREAM BED. WOUND APPEARS TO BE HEALING DUE TO THE BED AS BEEN SEPARATED INTO 2 AREAS BY PINK SKIN FORMING A BRIDGE ACROSS THE WOUND. EDGES ARE LESS DEFINED. BRIGHT PINK SKIN AROUND EDGES INDICATING NEW TISSUE GROW. THERE APPEARS TO NOT BE ANY DRAINAGE. IT WAS LATER REPORTED BY THE PATIENT (ON (B)(6) 2017),THAT THE CLEAR TUBING PROVIDED IN THE PICTURE IS THE PRODUCT THAT SHE IS ALLEGING. PATIENT STATES SHE DOES NOT HAVE ANY ALLERGY THAT SHE IS AWARE OF.