MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-27 for DERMAGRAN B- HYDROPHILIC GAUZE, 4" X 4" - STERILE SPD21 manufactured by Derma Sciences, Inc..
[96121463]
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[96121464]
It was reported that the patient called to report the use of product that expired in 2014 for treat a bed sore like wound on her rear end. She applied this dressing herself and is inquiring if it will do harm since it was expired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680091-2017-00100 |
| MDR Report Key | 7149711 |
| Date Received | 2017-12-27 |
| Date of Report | 2017-11-28 |
| Date Mfgr Received | 2018-01-03 |
| Date Added to Maude | 2017-12-27 |
| 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 | USER SONIA IRIZARRY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | DERMA SCIENCES, INC. |
| Manufacturer Street | 104 SHORTING ROAD |
| Manufacturer City | TORONTO, ONTARIO M1S 3S4 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | M1S 3S4 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DERMAGRAN B- HYDROPHILIC GAUZE, 4" X 4" - STERILE |
| Generic Name | DERMAGRAN |
| Product Code | MGP |
| Date Received | 2017-12-27 |
| Catalog Number | SPD21 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DERMA SCIENCES, INC. |
| Manufacturer Address | 104 SHORTING ROAD 104 SHORTING ROAD TORONTO, ONTARIO M1S 3S4 CA M1S 3S4 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-27 |