MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2011-02-25 for TIELLE HYDROPOLYMER ADHESIVE DRESSING MTL101 manufactured by Systagenix Wound Management Manufacturing.
[1935734]
(b)(4), lot number 0944112. Customer's grandmother was treating the wound with rayon (cellulose acetate) and the dr indicated the use of tielle. The pt was 2 days with the dressing feeling a lot of pain and bleeding. The bleeding that customer describes was exudate mixed with blood, and with red color such as blood. No medical intervention was required to stop bleeding.
Patient Sequence No: 1, Text Type: D, B5
[9096995]
Date sent to the fda (b)(6) 2011. Conclusion: no conclusion can be drawn at this time. The pt has a leg ulcer since (b)(6) of 2010. It has been in granulation stage with no edema associated, since (b)(6) 2010. She started the treatment with the dermatologist in (b)(6) and is now being treated with rayon again. The pain was treated with celebra 100 mg (anti-inflammatory, analgesic and antipyretic drug), cesaclor 500 (antibiotic) and deprosone (anti-inflammatory ointment). She has been using dipirona, pentoxifylline 400 ml and altargo (antibiotic ointment) since (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007663067-2011-00001 |
| MDR Report Key | 2007733 |
| Report Source | 00 |
| Date Received | 2011-02-25 |
| Date of Report | 2011-02-23 |
| Report Date | 2011-02-23 |
| Date Mfgr Received | 2011-02-09 |
| Device Manufacturer Date | 2009-10-01 |
| Date Added to Maude | 2011-03-08 |
| 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 | MRS. SAMANTHA KNIGHT |
| Manufacturer Street | AIREBANK MILL |
| Manufacturer City | GARGRAVE, N. YORKS, ENGLAND BD233RX |
| Manufacturer Country | UK |
| Manufacturer Postal | BD23 3RX |
| Manufacturer Phone | 56747465 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TIELLE HYDROPOLYMER ADHESIVE DRESSING |
| Generic Name | WOUND DRESSING |
| Product Code | MGP |
| Date Received | 2011-02-25 |
| Catalog Number | MTL101 |
| Lot Number | 0944/1/1/2 |
| Device Expiration Date | 2012-10-31 |
| 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 | SYSTAGENIX WOUND MANAGEMENT MANUFACTURING |
| Manufacturer Address | GARGRAVE, ENGLAND UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-02-25 |