MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-11 for BARD DISPOZ-A-BAG LEG BAG WITH FLIP-FLO DRAINAGE VALVE, FABRIC LEG STRAPS, 18IN 150832 manufactured by Productos Para El Cuidado De La Salud -9611590.
[72504953]
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 Sequence No: 1, Text Type: N, H10
[72504954]
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 Sequence No: 1, Text Type: D, B5
[74279454]
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 Sequence No: 1, Text Type: N, H10
[74279455]
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 Sequence No: 1, Text Type: D, B5
[86869965]
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 Sequence No: 1, Text Type: N, H10
[86869966]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2017-01706 |
| MDR Report Key | 6483520 |
| Date Received | 2017-04-11 |
| Date of Report | 2017-06-09 |
| Date Mfgr Received | 2017-05-12 |
| Date Added to Maude | 2017-04-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AMY GRAVLEY |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 |
| Manufacturer Street | KM. 7 CARRETERA INTERNACIONAL |
| Manufacturer City | NOGALES, SONORA 85621 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 85621 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD DISPOZ-A-BAG LEG BAG WITH FLIP-FLO DRAINAGE VALVE, FABRIC LEG STRAPS, 18IN |
| Generic Name | LEG BAG |
| Product Code | FAQ |
| Date Received | 2017-04-11 |
| Returned To Mfg | 2017-03-27 |
| Catalog Number | 150832 |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 |
| Manufacturer Address | KM. 7 CARRETERA INTERNACIONAL NOGALES, SONORA 85621 MX 85621 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-11 |