MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2013-09-25 for DURODERM CGF DRESSING 187661 manufactured by Convatec, Inc..
[3902922]
(b)(6) requested a report from boston medical care because a patient was re-hospitalized due to over infection of a wound. Boston medical care responded to (b)(6) with the following statement (translated version): the patient was originally assessed on (b)(4) at clinic where they were hospitalized for 1 month. During the hospitalization, according to the history report, the patient had a surgical debridement and treatment with antibiotics was initiated. It is important to note that the vital signs reported on (b)(6) on the clinical history was: temperature 37. 8 degree celsius, bp 89/55, fc 105. The next visits were made at home on (b)(6). The last visit that was made at home, the patient was found with a regular condition, bedridden, drowsy, accompanied by caregiver (son). Ulcers assessed found were: left trochanter wound with 70% granulation, 30% fibrin, macerated edge, highly exudative, exudate serous characteristic diameter 7x4 cm, uneven edges. Management begins with duoderm gel 30 g and duoderm cgf 15x15. Right trochanter wound with 100% wet necrotic tissue, deep but could not be assessed due to the necrotic tissue that covered all the wound bedding, edge villas, moderate exudate. Management begins with aquacel ag 10x10. Left heel wound with 30% granulation, 70% of fibrin, edge macerated, moderate exudate. Management begins with duoderm gel and duoderm cgf. Patient was without signs of infection, exudate observed at the last visit is characteristic of wound treated with these hydrocolloids. After washing the wound with plenty of saline, there was no clear sings of infection. Even with background of the hospitalization and conditions of injury, don't discontinue. The patient will continue with their infectious process or at least with a critical colonization, masked by the necrotic tissue. The caregiver did not report support with antibiotics after leaving the clinic. It was mentioned to the caregiver the importance of position changes and measures to manage pressure ulcers in order to improve them. It was noticed that there is not a caregiver permanently and this depends on patient's children according to their availability. During the next visit on (b)(6), the patient was hospitalized. As described above, we consider that the patient left his hospitalization with active infectious process.
Patient Sequence No: 1, Text Type: D, B5
[11282302]
Based on the available information, this event is deemed a serious injury. From a preliminary clinical perspective, a causal relationship between the device and this event is deemed unlikely as patient already had a poor medical history, had undergone a debridement (removal of dead, damaged, or infected tissue to improve the healing potential of the remaining healthy tissue) and had been placed on antibiotics before the use of the duoderm dressing product. No additional patient/ event details have been provided to date. Reported to fda on (b)(4) 2013.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1049092-2013-00047 |
| MDR Report Key | 3403196 |
| Report Source | 01,05,06,07 |
| Date Received | 2013-09-25 |
| Date of Report | 2013-08-27 |
| Date of Event | 2013-08-22 |
| Date Mfgr Received | 2013-08-27 |
| Date Added to Maude | 2013-10-11 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARY SZARO |
| 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 | DURODERM CGF DRESSING |
| Generic Name | OCCLUSIVE WOUND DRESSINGS |
| Product Code | MGP |
| Date Received | 2013-09-25 |
| Model Number | 187661 |
| Catalog Number | 187661 |
| Lot Number | 2K01554 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC, INC. |
| Manufacturer Address | 211 AMERICAN AVE. GREENSBORO NC 27409 US 27409 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2013-09-25 |