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 2013-11-14 for DUODERM - MOISTURE RETENTION CGF DRESSING 187987 manufactured by Convatec Limited.
[4038502]
It was reported that a patient was refered to (b)(6) for treatment on (b)(6) 2013. It was stated that she had a sacral ulcer of 10 cm x 7 cm diameter, depth unreadable, with 100 % dry necrotic tissue, loose edges, and moderate exudate not fetid or serous with sloughy surrounding skin. The patient had a right trochanter ulcer of 3 cm x 3 cm diameter, with 100% dry necrotic tissue, irregular borders, scant exudate not fetid and serous, and slight flush on surrounding skin. The patient also had a left trochanteric ulcer with 20 % surface 2 cm x 2 cm fibrin tissue and 80 % granulation tissue, irregular edges, exudate not fetid and serous, and the surrounding skin with slightly blush. It was reported that the wounds did not show signs of infection. Treatment on the ulcers began using aquacel (b)(4) dressing 10 x 10 cm and duoderm secondary cgf on wound one (1) and on wounds two (2) and (3) gel duoderm was applied and covered with duoderm cgf continuing every four (4) days. On (b)(6) 2013 two new pressure ulcers were identified. An external ulcer on the distal third part of the left inferior extremity, with 100 % fibrin. The second was a pressure ulcer on the left inner heel with a diameter of 1cm x 1cm with 70 % fibrin. Treatment was initiated for the two new ulcers with duoderm gel and covered with duoderm cgf. The trochanteric and sacral ulcers continued with the same wound management and the wound's edges were protected with zinc oxide. It was stated that the wounds did not have any obvious signs of infection during autolytic debridement process. It was emphasized to the caregivers to change the patient's position. On (b)(6) 2013, it was observed on the left trochanteric ulcers, which were separated by a bridge of skin, the wound bed had 100 % wet necrotic tissue. The same treatment was used on the patient and continued every four (4) days. On (b)(6) 2013 the patient was assessed by a doctor and the patient was found to be hemodynamically stable, without fiber, but the doctor stated the sacral and trochanteric wounds were over-infected. The doctor began treatment with oxacillin 1g, intravenous, every six (6) hours for ten (10) days and ordered daily treatment with saline and an application on the wounds of sulfamethoxazole timetropin - metronidazole tablets granulated with position changes every ten (10) minutes and medical assessment at the end of antibiotic treatment.
Patient Sequence No: 1, Text Type: D, B5
[11347411]
Based on the available information, this event is deemed a serious injury. The complaint has been evaluated by the site of mfg. An investigation was conducted and through the analysis of complaint data, a specific root cause could not be determined, as no product was returned. Based on the evaluation of the materials and processes, there was no change to the products that can indicate assignable situations that would account for the serious injury reported. The details of the investigation report. Skin related field feedback and/or complaints will continue to be tracked and evaluated according to procedure. No additional patient/event details have been provided to date. Should additional information become available a follow-up report will be submitted. A return sample for evaluation is not expected. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000317571-2013-00048 |
| MDR Report Key | 3491180 |
| Report Source | 01,05,06,07 |
| Date Received | 2013-11-14 |
| Date of Report | 2013-10-16 |
| Date of Event | 2013-10-08 |
| Date Mfgr Received | 2013-10-16 |
| Date Added to Maude | 2013-11-29 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARY SZARO, ASSOCIATE DIR |
| 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 | DUODERM - MOISTURE RETENTION CGF DRESSING |
| Generic Name | HYDROGEL WOUND AND BURN DRESSING |
| Product Code | MGQ |
| Date Received | 2013-11-14 |
| Model Number | 187987 |
| Catalog Number | 187987 |
| Lot Number | 3A00831 |
| 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 CH52NU UK CH5 2NU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-11-14 |