MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,foreign report with the FDA on 2015-06-15 for SUPRASORB X+PHMB 20542 manufactured by Lohmann & Rauscher International Gmbh & Co..
[6263824]
Systemic reaction of uncleared causality with suspicion of an anaphylactic reaction to the dressing suprasorb x +phmb - placed on a patient with large chronic and critically infected wound in the scalp/neck region - was described by a healthcare professional in new zealand. The pt concerned developed a tingling sensation after application of the dressing, with flushed red skin and an extensive raised papular rash on the upper body. He became tachycardic and hypotensive. After removing the dressing and comprehensive treatment, the pt was stable and made full recovery from the reaction. Please notice: a systemic antibiosis was given for a couple of days before the anaphylactoid reaction occurred and on the same day, the skin of the upper arm was disinfection with chlorhexidine and 0. 1% polyhexanide containing pronotosan cleansing solution. The event was evaluated by the manufacturer as a labeled-case and therefore a non-reportable expected and foreseeable adverse event, voluntarily reported to the authorities in (b)(4) via distributor.
Patient Sequence No: 1, Text Type: D, B5
[14245830]
Uncleared clinical causality. The side-effect was considered in the clinical evaluation and therefore evaluated as expected and foreseeable adverse event. The ifu already includes: "side-effects" in very rare cases skin irritations or allergies may occur. " risk analysis considered "allergic reactions" as known risk. Since suprasorb x+phmb was put into market by l&r in 2006 two cases with anaphylactoid reactions were reported. L&r is reported based on the draft guidelines "draft guidance for industry and fda staff - medical device reproting for manufacturers" issued on: (b)(4) 2013, section 4. 11. 3 l&r is marketing the following device that is of identical build in the unites states market: distributor ref: xyl040o210, mr. Ref (b)(4), xcell cellulose wound dressing antimicrobial, 5. 5" x 8", 510(k) #: c, mfr. :lohmann and rauscher (b)(4), johann-schorsch-gasse 4, 1141 wien, austria, registration#: (b)(4). Packaging was lost in hospital therefore lot # of the used device is not available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611462-2015-00001 |
| MDR Report Key | 4888427 |
| Report Source | 01,FOREIGN |
| Date Received | 2015-06-15 |
| Date of Report | 2015-06-11 |
| Date of Event | 2015-05-04 |
| Date Mfgr Received | 2015-04-05 |
| Date Added to Maude | 2015-07-06 |
| 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 Street | WESTERWALDSTR. 4 |
| Manufacturer City | RENGSDORF 56579 |
| Manufacturer Country | GM |
| Manufacturer Postal | 56579 |
| Manufacturer Phone | 2631996907 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPRASORB X+PHMB |
| Generic Name | ANTIMICROBIAL HYDROBALANCE WOUND DRE |
| Product Code | MGQ |
| Date Received | 2015-06-15 |
| Model Number | 20542 |
| Lot Number | UNK |
| ID Number | REF# 20542 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LOHMANN & RAUSCHER INTERNATIONAL GMBH & CO. |
| Manufacturer Address | NEUWIED, RHEINLAND-PFALZ GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-06-15 |