MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04,05,06,07 report with the FDA on 2013-09-30 for SAF-GEL - WOUND DRESSING W/ ALGINATE 145730 manufactured by Accupac, Inc.
[3870689]
The pt was seen at (b)(6) medical care on (b)(6) 2013, for an ulcer on their left lower leg (diameter 6x6 cm and 0. 5 cm deep). The wound was reportedly 90% dry fibrin tissue and 10% granulation tissue. The surrounding skin had signs of erythema, scaling, and heat extending to the lower portion of the limb. On the inside portion of the right lower leg it was reported all of the skin had edema, erythema, redness, flaking, and slough. A pedal pulse was present. The pt was treated with duoderm gcf on the ulcer (left leg) saf-gel and flexidress on both lower legs. The same dressings were re-applied on (b)(6) 2013. On (b)(6) 2013, the pt had an increase in edema in the lower right leg along with heat, redness,swelling, rash, and slough (diameter of 20x20 cm). On the lower left leg the ulcer was still present (5x4 cm) along with fibrinoid tissue decrease, increased erythema, pain, edema, and itching so the flexidress and saf-gel were discontinued. The pt also had redness, swelling and itching on their face and arms. Both of the pt's wounds were redressed with petroleum jelly and gauze and the pt was told to go to the emergency room for a medical evaluation. On (b)(6) 2013, the pt saw a doctor and they were told they were having an allergic reaction to flunarizine which they took on (b)(6) 2013. The pt was taken off of the flunarizine and started taking cephalexin 500mg every 6 hours for 10 days along with ibuprofen. On (b)(6) 2013, it was reported the pt stated they began taking cephalexin and the ibuprofen and had a decrease in inflammation and rash (including on their hands and face). On (b)(6) 2013, the pt was restarted on the flexidress, saf-gel, and duoderm cgf on lower left leg and aquacel (15x15 cm) and flexidress on the right leg. The pt received two additional treatments on (b)(6) 2013. On (b)(6) 2013, the pt returned to (b)(6) medical care and stated they were experiencing pain, heat, and redness. The pt's legs were treated with vaseline and covered with gauze. The ulcer on the left leg was treated with duoderm cgf and gel.
Patient Sequence No: 1, Text Type: D, B5
[11220262]
Based on the available information, this event is deemed a serious injury. The pt was referred back to the doctor on (b)(6) 2013. Quality records were reviewed by the third party manufacturer and no non-conformances were identified. A batch record review found all items correct and no irregularities in production. From a clinical perspective, a causal relationship between the saf-gel wound dressing w/ alginate and this event is deemed probable because product use is temporarily associated with the skin where the problem occurred. No additional pt/event details have been provided to date. Should additional information become available, a follow-up report will be submitted. A return sample for eval is not expected. (b)(4). Third party mfr: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243969-2013-00104 |
| MDR Report Key | 3381076 |
| Report Source | 01,04,05,06,07 |
| Date Received | 2013-09-30 |
| Date of Report | 2013-08-30 |
| Date of Event | 2013-08-13 |
| Date Mfgr Received | 2013-08-30 |
| Device Manufacturer Date | 2012-07-01 |
| Date Added to Maude | 2013-10-03 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARY SZARO, ASSOC DIRECTOR |
| Manufacturer Street | 200 HEADQUARTERS PARK DR. |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089042450 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAF-GEL - WOUND DRESSING W/ ALGINATE |
| Generic Name | HYDROGEL WOUND AND BURN DRESSING |
| Product Code | NAE |
| Date Received | 2013-09-30 |
| Model Number | 145730 |
| Catalog Number | 145730 |
| Lot Number | 1952A3 |
| Device Expiration Date | 2014-07-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCUPAC, INC |
| Manufacturer Address | 1501 INDUSTRIAL BLVD PO BOX 200 MAINLAND PA 19451020 US 19451 0200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-09-30 |