MAUDE Adverse Event Report: LOHMANN & RAUSCHER GMBH & CO SUPRASORB X+PHMB; ANTIMICROBIAL WOUND DRESSING, STERILE

Model Number 14X20CM

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/03/2020

Event Type  Death  

Manufacturer Narrative

The manufacturer lohmann & rauscher (b)(4) notified it's subsidiary and us importer, (b)(4) of this event; therefore (b)(4) did not have to report this event back to the manufacturer.(b)(4) is reporting an adverse event as identified in (b)(6) for suprasorb x+phmb as the importer.While suprasorb x+phmb was never distributed within the usa it is a fda listed device for lohmann & rauscher (b)(4); however, a similar device was distributed as xcell¿ cellulose wound dressing antimicrobial, sterile 3.5 in.X 3.5 in.Under the lohman & rauscher brand and was distributed within the usa.This product was last sold in the usa on september 2018, and has subsequently exceeded it's expiration date.Both suprasorb x+phmb and xcell antimicrobial products have been discontinued, and (b)(4) (importer) will remove listing, d297355, for xcell and suprasorb x associated with product code mgq to remove their respective proprietary names.

Event Description

Through this communication, on behalf of lohmann & rauscher we would like to inform you that on the (b)(6) 2020, we received a report from dr.(b)(6) of the burned children unit of the state center for critical care in (b)(6), institute of public health of the state of (b)(6), referring to a (b)(6)-year-old male child who was admitted to the general hospital of (b)(6) due to a burn with hot water suffered on (b)(6) on the genital area and the lower extremities (approx.21% of the body area) and who was later transferred to the burned children unit of the state center for critical care of (b)(6), institute of public health of the state of (b)(6) on (b)(6).After the 3rd surgical debridement the child was treated with 5 pieces of our suprasorb x+phmb wound dressing (14x20 cm, ref: 20542, lot: 1913311905) for 4-5 days without any change dressing (fixed as secondary dressing with an unelastic bandage).According to the medical report and the (b)(6) report sent by dr.(b)(6) to us the first symptoms were presented by the patient in the first 24 h up to severe liver failure and acute kidney failure and later died on (b)(6).The patient was co-treated with different medications such as paracetamol, dexmedetomidine, diphenhydramine, loratadine, cephalotin, amikacin, diphenhydramine, albendazole, among others, and additionally during treatment, the suprasorb x + phmb wound dressing was used.Lohmann & rauscher is currently conducting an evaluation of this case in order to determine the causal relationship (if there is any correlation between the event presented and the use of the suprasorb x + phmb wound dressing).Once the evaluation has been completed, we will submit a new notification to you with the results.

Manufacturer Narrative

The manufacturer lohmann & rauscher (b)(4) notified it's subsidiary and us importer, l&r usa inc.Of this event; therefore l&r usa inc did not have to report this event to the manufacturer.L&r usa inc.Is reporting an adverse event as identified in (b)(6) for suprasorb x+phmb as the importer.While suprasorb x+phmb was never distributed within the usa by either l&r usa inc., or lohmann & rauscher (b)(4).A similar device was distributed.The similar device is labeled as xcell¿ cellulose wound dressing antimicrobial, sterile 3.5 in.X 3.5 in.Under the lohman & rauscher brand and is identical in specifications to suprasorb x+phmb with the exception of package labeling & ifu.Xcell¿ cellulose wound dressing antimicrobial, sterile 3.5 in.X 3.5 in was distributed within the usa by l&r usa inc.The xcell product was last distributed within the usa on september 2018, and has subsequently exceeded it's expiration date.Xcell antimicrobial products have been discontinued, and l&r usa inc.(importer) will remove listing, (b)(4), for xcell associated with product code mgq to remove the proprietary name from this listing.Suprasorb x+phmb was never listed with the fda for distribution in the united states by either lohmann & rauscher (b)(4) or l&r usa inc.Follow up report with information to support fda mdr response via ai letter (b)(4) as found in attachment 4.Lohmann & rauscher (b)(4) has supplied a formal response to the fda's questions as found in attachment 5.This response also include references to attachments 6, reporting facility event history analysis spreadsheet.

Event Description

Through this communication, on behalf of lohmann & rauscher we would like to inform you that on the (b)(6) 2020, we received a report from dr.(b)(6) of the burned children unit of the state center for critical care in (b)(6), referring to a (b)(6)-year-old male child who was admitted to the general hospital of (b)(6) due to a burn with hot water suffered on (b)(6) on the genital area and the lower extremities (approx.21% of the body area) and who was later transferred to the burned children unit of the state center for critical care of (b)(6) on (b)(6).After the 3rd surgical debridement the child was treated with 5 pieces of our suprasorb x+phmb wound dressing (14x20cm, ref 20542, lot 1913311905, description for 4-5 days without any change dressing (fixed as secondary dressing with an unelastic bandage.According to the medical report and the cofebris report sent by dr.(b)(6) to us the first symptoms were presented by the patient in the first 24 h up to severe liver failure and acute kidney failure and later died on (b)(6).The patient was co-treated with different medications such as paracetamol, dexmedetomidine, diphenhydramine, loratadine, cephalotin, amikacin, diphenhydramine, albendazole, among others, and additionally during treatment, the suprasorb x + phmb wound dressing was used.For more details please refer to the document which corresponds to the clinical history of the patient received by dr.(b)(6) (received (b)(6) 2020) as well as the report made by dr.(b)(6) to cofepris (received (b)(6) 2020).Lohmann & rauscher is currently conducting an evaluation of this case in order to determine the causal relationship (if there is any correlation between the event presented and the use of the suprasorb x + phmb wound dressing).Once the evaluation has been completed, we will submit a new notification to you with the results.

• Brand Name: SUPRASORB X+PHMB
• Type of Device: ANTIMICROBIAL WOUND DRESSING, STERILE
• Manufacturer (Section D): LOHMANN & RAUSCHER GMBH & CO; irlicher strasse 55; neuwied, rhineland-palatinate 56579 ; GM 56579
• MDR Report Key: 10218906
• MDR Text Key: 197172675
• Report Number: 2135152-2020-00001
• Device Sequence Number: 1
• Product Code: MGQ
• UDI-Device Identifier: 04021447688367
• UDI-Public: 4021447688367
• Combination Product (y/n): N
• Reporter Country Code: MX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 14X20CM
• Device Catalogue Number: 20542
• Device Lot Number: 4021447924816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/10/2020
• Device Age: 1 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/01/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Disability
• Patient Age: 5 YR
• Patient Weight: 13