MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07,company represent report with the FDA on 2013-11-14 for DUODERM - MOISTURE RETENTION CGF DRESSING 187662 manufactured by Convatec Inc.
[4003989]
It was reported that a patient was referred to (b)(6) medical care for treatment on (b)(6) 2013. It was stated that she had a sacral ulcer of 10cm x 7cm 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 3cm x 3cm diameter, with 100% dry necrotic tissue, irregular boarders, scant exudate not fetid and serous, and slight flush on surrounding skin. The patient also had a left trochanteric ulcer with 20% surface 3cmx 2cm fibrin tissue and 80% granulation tissue, irregular edges, exudate not fetid and serous, and the surrounding skin with slight blush. It was reported that the wound did not show signs of infection. Treatment on the ulcers began using aquacel ag dressing 10 x 10cm and duoderm secondary cgf on wound one (1) and 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 trochanteric and sacral ulcers continued with the same wound management and 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. On the right trochanter six small ulcers separated by a bridge of skin, with 100% of necrotic tissue. The same treatment was used on the patient and continued every four (4) days. (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 positon changes every ten (10) minutes and a medical assessment at the end of antibiotic treatment.
Patient Sequence No: 1, Text Type: D, B5
[11347841]
Based on the available information this event is deemed a serious injury. 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
[28374716]
Additional information was received on september 23, 2015. The product associated with lot# 2d01012 was made according to specifications. No precious investigations are available. After a thorough batch review no discrepancies or non-conformances were discovered. There is not enough information to conclude the product did not meet specification and perform as intended. Product monitoring reviews will monitor for product trends if this issue were to reoccur. No further actions are required and the complaint will be closed. No additional patient/event details have been provided to date. Should additional information become available a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1049092-2013-00221 |
| MDR Report Key | 3491211 |
| Report Source | 01,05,06,07,COMPANY REPRESENT |
| Date Received | 2013-11-14 |
| Date of Report | 2013-10-16 |
| Date of Event | 2013-10-08 |
| Date Mfgr Received | 2015-09-23 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR MATTHEW WALENCIAK |
| Manufacturer Street | 211 AMERICAN AVENUE |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 9083779293 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUODERM - MOISTURE RETENTION CGF DRESSING |
| Generic Name | OCCLUSIVE WOUND DRESSINGS |
| Product Code | MGP |
| Date Received | 2013-11-14 |
| Model Number | 187662 |
| Catalog Number | 187662 |
| Lot Number | 2D01012 |
| 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. Required No Informationntervention | 2013-11-14 |