MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-06-03 for #5 ABRA BUTTON ANCHOR SWK07 manufactured by Canica Design, Inc..
[2687032]
The pt is a (b)(6) male who was transferred to (b)(6) with a diagnosis of necrotizing pancreatitis. The pt underwent a laparotomy and debridement of necrotizing pancreatitis on (b)(6) 2009, that resulted in an open abdomen. The pt was enrolled into the (b)(4) study, and the abra device was placed on (b)(6) 2009. A mass amount of drainage and infection, along with the absence of wound edge approx for greater than three days required abra device removal. On (b)(6) 2009, following abra device removal, two jackson pratt drains were placed where the pancreatic drainage occurred, along with placement of a wound vac system. During the procedure it was noted that soft tissue debridement was needed on the skin where the abra device button pads previously rested. The debrided areas were covered with the wound vac sponge and were contained under the wound vac dressing. The event was reviewed by the site approved data safety monitoring board and the event was reported to the local (b)(6) on (b)(6) 2009. It was noted during an internal audit that the event hadn't been reported to the sponsor. This was an oversight and once noticed the report was promptly submitted.
Patient Sequence No: 1, Text Type: D, B5
[9964760]
Eval of the event was completed through review of the pt's record with the surgeon, dr (b)(6), who believes there was no device failure, and that the pt's overall fragile condition pre-disposed him to skin ulceration under the button anchors. It cannot be determined if maintenance instructions to clean and dry under the buttons every 12 hrs (as specified in the instructions for use) were followed to prevent skin breakdown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616525-2010-00001 |
| MDR Report Key | 2554701 |
| Report Source | 06 |
| Date Received | 2010-06-03 |
| Date of Report | 2010-05-20 |
| Date of Event | 2009-07-20 |
| Date Facility Aware | 2009-07-20 |
| Report Date | 2010-05-21 |
| Date Reported to Mfgr | 2010-05-27 |
| Date Mfgr Received | 2010-05-27 |
| Device Manufacturer Date | 2007-08-01 |
| Date Added to Maude | 2012-05-03 |
| 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 Street | 36 MILL ST. |
| Manufacturer City | ALMONTE, ONTARIO K0A 1L0 |
| Manufacturer Country | CA |
| Manufacturer Postal | K0A 1L0 |
| Manufacturer Phone | 6132560350 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | #5 ABRA BUTTON ANCHOR |
| Generic Name | RETENTION DEVICE, SUTURE |
| Product Code | KGS |
| Date Received | 2010-06-03 |
| Model Number | SWK07 |
| Lot Number | 6907 (FROM SET J11) |
| Device Expiration Date | 2011-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CANICA DESIGN, INC. |
| Manufacturer Address | ALMONTE, ONTARIO CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-06-03 |