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 2014-04-15 for MOISTURE RETENTIVE DUODERM CGF DRESSING 187987 manufactured by Convatec Limited.
[4415324]
Daughter of patient reported that patient was being treated with healing for multiple wounds on both legs with oral antibiotics and various dressings, which became infected and he was taken to emergency where he was hospitalized from (b)(6) 2014 resulting in amputation from his left leg (unknown level). Summary of patient care as follows: the patient admission to the hospital for cures on (b)(6) 2014, related to three traumatic lower limb injuries. Patient entered to the appointment on crutches. The wound assessment at admission three lesions were found: injury to the middle third of lower left member 8x8. 5cm with 100% dry necrotic tissue, perilesional skin with redness, heat, swelling, pain (signs of infection); injury to the middle third right lower frontal member 1x1cm with 100% dry necrotic tissue and adhered; wounded in right knee 1x1cm on right knee with 100% necrotic tissue, perilesional healthy skin. Treatment was initiated with duoderm gel to promote debridement of necrotic tissue, aguacel ag for handling of local bacteria load, and duoderm cgf dressing to add moisture to the wound. Healings were scheduled every five days. Patient and family were educated in dressings' technology behavior, especially the effect of debridement causing an increase in the size of the wounds. Indications were given for warning signs. During healing made between (b)(6) 2014, it was observed that necrotic tissue still persists as evidenced by wetter and enlarged wounds (debridement effect, equal management was continued and having present that the patient had significantly increased in pain, edema). Flushing it and was told to consult his doctor. On (b)(6) 2014, patient was assisted to the appointment due to difficulties walking, edema grade ii, and two injured more appearance and remarkable enlargement of existing wounds: wound no. 1: middle third lower left member 14x13cm with 100% wet necrotic tissue, slough edges, with signs of infection; wound no. 2: injury on frontal middle third lower right member 18x7cm with 30% wet and 70% necrotic tissue granulation, heavy exudate, with signs of infection; wound no. 3: injury 1x1cm right knee with 100% fibrin tissue. Macerated edges new lesions; wound no. 4: injury on frontal third proximal left lower, member 8x5c bottom with bleeding, highly exudative; wound no. 5: injury supramalleolar external region of left lower limb with granular background 6x4cm. Management continues with aguacel ag, duoderm gel and duoderm cgf. Patient and family (son) was informed on the importance of being evaluated by an internists due to deterioration of general condition, and the wound is very strong which requires ancillary diagnostic tests. Family reported that patient already had a scheduled appointment with doctor for evaluation. On (b)(6) 2014, patient enters to healing process on wheelchair, in poor general condition, pale polipnea. Family reported that patient has not been eating well (diabetic). Right frontal wound of lower limb, in addition to what was described in the previous healing presented with ischemic edges, surrounding with slough skin, edema grade iii, weak pulses without capillary refill. Wound on the third distal outer side of the leg: 8x7cm 100% wet necrotic tissue, ischemic edges surrounding skin macerated, increased serious exudates, edema grade iv decreased popliteal pulse, no palpable pedal and tibial, without capillary refill, cold extremity. Due to the marked deterioration, and patient not yet been evaluated by the physician, wound healing was done. Family was informed that he be taken to emergency assessment by his eps. In conclusion, it is reported that when it was identified that the patient did not improve and had not been reviewed by a physician (as recommended), ths nurse who referred him to the emergency service, in addition to his underlying preexisting medical condition, may have put him at greater risk of complication. Treatment was performed to the patient aimed at enhancing autolytic debridement of all necrotic lesions being the predominant tissue in all wounds and aquacel ag to decrease local bacterial load.
Patient Sequence No: 1, Text Type: D, B5
[11767627]
Based on the available information, this event is deemed a serious injury; however, report states the complaint is not related to the dressing use, but reallocation of postoperative healings at the same institution where he was operated. Case was evaluated by quality on (b)(6) 2014 based on the review of the batch record for due diligence. Results show that the product was manufactured to specification. In addition, the complaint letter states that the complaint is not regarding the dressing but the reallocation of healings at the institution. No further action required as per convatec governing complaint and handling procedure. Reported to the fda on (b)(4) 2014. Convatec will continue to track and monitor such complaints according to it's complaint handling and capa procedures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000317571-2014-00016 |
| MDR Report Key | 3761035 |
| Report Source | 01,04,05,06,07 |
| Date Received | 2014-04-15 |
| Date of Report | 2014-03-21 |
| Date of Event | 2014-02-18 |
| Date Mfgr Received | 2014-03-21 |
| Date Added to Maude | 2014-04-22 |
| 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 | MATTHEW WALENCIAK, INTERIM ASSOC. |
| Manufacturer Street | 200 HEADQUARTERS PARK DR. |
| Manufacturer City | SKILLMAN NJ 085558 |
| Manufacturer Country | US |
| Manufacturer Postal | 085558 |
| Manufacturer Phone | 9083779293 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOISTURE RETENTIVE DUODERM CGF DRESSING |
| Generic Name | HYDROGEL WOUND AND BURN DRESSING, 79 NAE |
| Product Code | NAE |
| Date Received | 2014-04-15 |
| Model Number | 187987 |
| Catalog Number | 187987 |
| Lot Number | 3H02261 |
| 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 LIMITED |
| Manufacturer Address | FIRST AVENUE DEESIDE INDUSTRIAL PARK DEESIDE, FLINTSHIRE CH52NU UK CH5 2NU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-04-15 |